A Study to Examine the Effects of an Experimental Drug on... | NCT00112437 | Trialant
NCT00112437
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jan 24, 2018Actual
Enrollment
399Actual
Phase
Phase 2
Conditions
Osteoporosis
Interventions
Odanacatib
Odanacatib
Odanacatib
Odanacatib
Vitamin D3
Calcium Carbonate
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00112437
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0822-004
Secondary IDs
ID
Type
Description
Link
2005_023
Brief Title
A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin K Inhibitor) in the Treatment of Postmenopausal Women With Osteoporosis
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Dec 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 24, 2005Actual
Primary Completion Date
Dec 26, 2007Actual
Completion Date
Jan 20, 2016Actual
First Submitted Date
Jun 2, 2005
First Submission Date that Met QC Criteria
Jun 2, 2005
First Posted Date
Jun 3, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 13, 2010
Results First Submitted that Met QC Criteria
Apr 13, 2010
Results First Posted Date
May 13, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 21, 2017
Last Update Posted Date
Jan 24, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib [MK-0822]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).
Detailed Description
Study Extension:
Participants who completed 12 months of the base study and 12 months of the first extension were invited to continue in three additional extensions: MK0-822-004-10, which extended the study to 36 months, MK-0822-004-20 (NCT00112437) which extended the study to 60 months, and MK-0822-004-30 (NCT00112437), which extended the study to 120 months.
In the first extension, participants continued to receive the same treatment they received in the 12-month base study.
In the second extension, participants were re-randomized to odanacatib 50 mg OW or placebo OW for 12 months.
In the third extension, participants who were initially randomized to odanacatib 3 mg or placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5; all other participants remained on the same treatment they were during Year 3.
In the fourth extension, all participants received odanacatib weekly in Years 6-10.
Study arms for extensions include only odanacatib 50 mg and placebo for the first two extensions and odanacatib 50 mg only for the third extension.
Extension Studies:
MK-0822-004-10 (NCT00112437) Extension: Participant has participated in and completed 24 months of treatment in the base study
MK-0822-004-20 (NCT00112437) Extension: Participant participated in and completed 36 months of treatment in base and extension studies.
MK-0822-004-30 (NCT00112437) Extension: Participant participated in and completed 60 months of treatment in the base and extension studies.
Conditions Module
Conditions
Osteoporosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
399Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Drug: Placebo
Odanacatib 3 mg
Experimental
Drug: Odanacatib
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Odanacatib 10 mg
Experimental
Drug: Odanacatib
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Odanacatib 25 mg
Experimental
Drug: Odanacatib
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Odanacatib 50 mg
Experimental
Drug: Odanacatib
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium Carbonate
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Odanacatib
Drug
Odanacatib 3 mg, once weekly for 24 months
Odanacatib 3 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
Baseline and 12 months
Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
Baseline and 24 months
Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
Percentage change in lumbar spine BMD (relative to baseline) at 36 months
Baseline and 36 months
Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
Percentage change from baseline in lumbar spine BMD at 60 months.
Baseline and Month 60
Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
Percentage change from baseline in lumbar spine BMD at 120 Months.
Baseline and Month 120
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
Secondary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Total Hip BMD at 12 Months
Percentage change in total hip BMD (relative to baseline) at 12 months
Baseline and 12 months
Percentage Change From Baseline in Femoral Neck BMD at 12 Months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
Bone mineral density T-score at the hip or spine of -2.0 or less
Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures)
In a state of general health allowing for successful completion of the trial
Agreement to not use any medications to treat osteoporosis during the study
Exclusion Criteria:
History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy)
Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details)
Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason)
Bone HG, McClung MR, Roux C, Recker RR, Eisman JA, Verbruggen N, Hustad CM, DaSilva C, Santora AC, Ince BA. Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res. 2010 May;25(5):937-47. doi: 10.1359/jbmr.091035.
Participants entered screening followed by a 3-week placebo run-in. All took vitamin D3, 5600 IU once weekly, those with average daily calcium intakes <1000 mg took calcium 500 mg/day as calcium carbonate. Participants were excluded from the active treatment based on predetermined exclusion criteria (Bone Mineral Density and laboratory results).
Recruitment Details
Approximately 375 participants were recruited from June 2005 to December 2005. Investigators used one or more of the following recruitment methods: Investigator Patient/Subject Database or Medical Records, Investigator's Local Recruitment/Advertising, Other Health Professional and, Physician Referral (Primary/Specialist/Family Doctor).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo-Base
One placebo tablet once a week
FG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
FG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
FG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
FG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
FG005
Placebo-Ext 1
One placebo tablet once a week
FG006
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
FG007
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
FG008
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
FG009
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
FG010
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
FG011
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
FG012
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
FG013
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
FG014
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
FG015
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
FG016
Odanacatib 25 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
FG017
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
FG018
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
FG019
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
FG020
Placebo Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one placebo tablet once a week.
FG021
Odanacatib 50 mg Once Weekly-Ext 3
During this 24-month extension (Years 4-5), participants in this treatment group received one odanacatib 50 mg tablet once a week.
FG022
Group A: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group A consisted of a combination of participants who were treated with odanacatib 25 mg for 2 years,then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
FG023
Group B: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group B consisted of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
FG024
Group C: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet one a week. Group C consisted of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
FG025
Group D: Odanacatib 50 mg Once Weekly-Ext 4
During this 60-month extension (Years 6-10), participants in this treatment group received one odanacatib 50 mg tablet once a week. Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
Periods
Title
Milestones
Reasons Not Completed
Year 1 (12-Month Base Study)
Type
Comment
Milestone Data
STARTED
FG00083 subjects
FG00182 subjects
FG00277 subjects
FG00379 subjects
FG004
COMPLETED
FG00068 subjects1 patient completed base study after December 19, 2006 and is not included in completed total.
FG00164 subjects1 patient completed base study after December 19, 2006 and is not included in completed total.
FG00265 subjects
FG003
NOT COMPLETED
FG00015 subjects
FG00118 subjects
FG00212 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG00110 subjects
FG0026 subjects
FG003
Year 2 (12-Month Extension)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Year 3 (12-Month Extension)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Years 4-5 (24-Month Extension)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Years 6-10 (60-Month Extension)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo-Base
One placebo tablet once a week
BG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
Analysis at Month 12 used Full-Analysis-Set Population of participants who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse Events data were collected up to 120 months (from start of study medication, up to 14 days after the last dose).
Description
The Safety Analysis was based on the All Participants as Treated (APaT) population, which included all participants who took at least one dose of study medication.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Years 1-2 Placebo/Placebo-Ext 1
One placebo tablet once a week
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriospasm Coronary
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Australia
Austria
Chile
Colombia
Denmark
France
Mexico
Netherlands
New Zealand
Norway
Peru
Sweden
Switzerland
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D010024
Osteoporosis
Ancestor Terms
ID
Term
D001851
Bone Diseases, Metabolic
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D008659
Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C527128
odanacatib
D002762
Cholecalciferol
D002119
Calcium Carbonate
Ancestor Terms
ID
Term
D002782
Cholestenes
D002776
Cholestanes
D013256
Steroids
D000072473
Fused-Ring Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
MK-0822
Odanacatib
Drug
Odanacatib 10 mg, once weekly for 24 months
Odanacatib 10 mg
MK-0822
Odanacatib
Drug
Odanacatib 25 mg, once weekly for 24 months
Odanacatib 25 mg
MK-0822
Odanacatib
Drug
Odanacatib 50 mg, once weekly for 24 months
Odanacatib 50 mg
MK-0822
Vitamin D3
Dietary Supplement
Vitamin D3, two 2800 IU weekly throughout the study
Odanacatib 10 mg
Odanacatib 25 mg
Odanacatib 3 mg
Odanacatib 50 mg
Placebo
Calcium Carbonate
Dietary Supplement
Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.
Odanacatib 10 mg
Odanacatib 25 mg
Odanacatib 3 mg
Odanacatib 50 mg
Placebo
Placebo
Drug
Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months
Placebo
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Years 6-10 (up to 60 months)
Percentage change in femoral neck BMD (relative to baseline) at 12 months
Baseline and 12 months
Percentage Change From Baseline in Trochanter BMD at 12 Months
Percentage change in trochanter BMD (relative to baseline) at 12 months
Baseline and 12 Months
Percentage Change From Baseline in Total Body BMD at 12 Months
Percentage change in total body BMD (relative to baseline) at 12 months
Baseline and 12 Months
Percentage Change From Baseline in Distal Forearm BMD at 12 Months
Percentage change in distal forearm BMD (relative to baseline) at 12 months
Baseline and 12 Months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months
Baseline and 12 Months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.
Baseline and 12 Months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months
Baseline and 12 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months
Baseline and 12 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months
Baseline and 12 months
Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Femoral Neck BMD at 24 Months
Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Trochanter BMD at 24 Months
Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Total Body BMD at 24 Months
Percentage change in total body BMD (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Distal Forearm BMD at 24 Months
Percentage change in distal forearm BMD (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
Baseline and 24 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months
Baseline and 24 months
Percentage Change From Baseline in Total Hip BMD at 36 Months
Percentage change in total hip BMD (relative to baseline) at 36 months
Baseline and 36 months
Percentage Change From Baseline in Femoral Neck BMD at 36 Months
Percentage change in femoral neck BMD (relative to baseline) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Trochanter BMD at 36 Months
Percentage change in trochanter BMD (relative to baseline) at 36 months
Baseline and 36 months
Percentage Change From Baseline in Total Body BMD at 36 Months
Percentage change from baseline in total body BMD (relative to baseline) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Distal Forearm BMD at 36 Months
Percentage change in distal forearm BMD (relative to baseline) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months
Baseline and 36 months
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
Baseline and 36 months
Langdahl B, Binkley N, Bone H, Gilchrist N, Resch H, Rodriguez Portales J, Denker A, Lombardi A, Le Bailly De Tilleghem C, Dasilva C, Rosenberg E, Leung A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase 2 study. J Bone Miner Res. 2012 Nov;27(11):2251-8. doi: 10.1002/jbmr.1695.
Rizzoli R, Benhamou CL, Halse J, Miller PD, Reid IR, Rodriguez Portales JA, DaSilva C, Kroon R, Verbruggen N, Leung AT, Gurner D. Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study. Osteoporos Int. 2016 Jun;27(6):2099-107. doi: 10.1007/s00198-016-3503-0. Epub 2016 Feb 15.
Eisman JA, Bone HG, Hosking DJ, McClung MR, Reid IR, Rizzoli R, Resch H, Verbruggen N, Hustad CM, DaSilva C, Petrovic R, Santora AC, Ince BA, Lombardi A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: three-year continued therapy and resolution of effect. J Bone Miner Res. 2011 Feb;26(2):242-51. doi: 10.1002/jbmr.212.
78 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
71 subjects
FG00466 subjects1 patient completed base study after December 19, 2006 and is not included in the completed total.
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
12 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
4 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Withdrawal by Subject
FG0005 subjects
FG0015 subjects
FG0022 subjects
FG0031 subjects
FG0047 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
moved
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
patient was unsure that they needed drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
DXA was lower by more than 8%
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
0 subjects
FG0040 subjects
FG00563 subjects
FG00662 subjects
FG00763 subjects
FG00869 subjects
FG00963 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00560 subjects
FG00653 subjects
FG00755 subjects
FG00862 subjects
FG00950 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0069 subjects
FG0078 subjects
FG0087 subjects
FG00913 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0076 subjects
FG0081 subjects
FG0097 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient stopped taking medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
patient was out of windows
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Moved
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG01019 subjects
FG01122 subjects
FG01218 subjects
FG01317 subjects
FG01418 subjects
FG01517 subjects
FG01619 subjects
FG01721 subjects
FG01818 subjects
FG01920 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG01017 subjects
FG01117 subjects
FG01218 subjects
FG01316 subjects
FG01417 subjects
FG01513 subjects
FG01616 subjects
FG01720 subjects
FG01816 subjects
FG01919 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0115 subjects
FG0120 subjects
FG0131 subjects
FG0141 subjects
FG0154 subjects
FG0163 subjects
FG0171 subjects
FG0182 subjects
FG0191 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0163 subjects
FG0171 subjects
FG0180 subjects
FG0191 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
cortisone therapy, upcoming surgery
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG02041 subjects
FG021100 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG02037 subjects
FG02192 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0204 subjects
FG0218 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0202 subjects
FG0211 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Discontinued for other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant moved
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG02228 subjects
FG02334 subjects
FG02423 subjects
FG02532 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG02223 subjects
FG02322 subjects
FG02422 subjects
FG02527 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0225 subjects
FG02312 subjects
FG0241 subjects
FG0255 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0221 subjects
FG0232 subjects
FG0240 subjects
FG0251 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
BG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
BG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
BG005
Total
Total of all reporting groups
83
BG00182
BG00277
BG00379
BG00478
BG005399
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065.9± 7.8
BG00163.1± 7.3
BG00264.5± 8.0
BG00362.9± 7.4
BG00464.5± 8.1
BG00564.2± 7.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00083
BG00182
BG00277
BG00379
BG00478
BG005399
Male
BG0000
BG0010
BG0020
BG0030
BG004
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00081
OG00179
OG00277
OG00378
OG00477
Title
Denominators
Categories
Title
Measurements
OG000-0.13(-0.80 to 0.54)
OG001-0.62(-1.30 to 0.05)
OG0021.50(0.82 to 2.19)
OG0032.65(1.97 to 3.33)
OG0043.37(2.68 to 4.05)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
3.50
2-Sided
95
2.54
4.45
Superiority or Other
OG000
OG003
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
2.78
2-Sided
95
1.82
3.73
Superiority or Other
OG000
OG002
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.003
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
1.63
2-Sided
95
0.68
2.59
Superiority or Other
OG000
OG001
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.343
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
-0.49
2-Sided
95
-1.44
0.46
Superiority or Other
Primary
Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
Analysis on lumbar spine BMD (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00062
OG00158
OG00260
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.19(-1.13 to 0.75)
OG001-1.03(-2.00 to -0.07)
OG0023.20(2.25 to 4.15)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
5.67
2-Sided
95
4.32
7.02
Secondary
Percentage Change From Baseline in Total Hip BMD at 12 Months
Percentage change in total hip BMD (relative to baseline) at 12 months
This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00081
OG00179
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.61(-1.22 to -0.01)
OG001-1.36(-1.97 to -0.75)
OG0021.05(0.44 to 1.67)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
2.49
2-Sided
95
1.62
3.35
Secondary
Percentage Change From Baseline in Femoral Neck BMD at 12 Months
Percentage change in femoral neck BMD (relative to baseline) at 12 months
This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00081
OG00179
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.13(-0.79 to 0.54)
OG001-0.32(-0.99 to 0.35)
OG0020.74(0.05 to 1.42)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
2.66
2-Sided
95
1.71
3.61
Secondary
Percentage Change From Baseline in Trochanter BMD at 12 Months
Percentage change in trochanter BMD (relative to baseline) at 12 months
This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 Months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00081
OG00179
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.73(-1.64 to 0.18)
OG001-1.02(-1.94 to -0.10)
OG0021.65(0.72 to 2.58)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
2.94
2-Sided
95
1.64
4.24
Secondary
Percentage Change From Baseline in Total Body BMD at 12 Months
Percentage change in total body BMD (relative to baseline) at 12 months
This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 Months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00072
OG00171
OG00270
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.42(-1.16 to 0.32)
OG001-1.89(-2.64 to -1.14)
OG002-1.06(-1.81 to -0.30)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.112
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
0.29
2-Sided
95
-0.77
1.35
Secondary
Percentage Change From Baseline in Distal Forearm BMD at 12 Months
Percentage change in distal forearm BMD (relative to baseline) at 12 months
This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 Months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00081
OG00179
OG00277
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.27(-1.98 to -0.57)
OG001-2.55(-3.26 to -1.83)
OG002-1.00(-1.73 to -0.28)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
1.23
2-Sided
95
0.22
2.24
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 Months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00062
OG00157
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.37(-14.78 to 11.85)
OG0018.80(-5.50 to 25.27)
OG002-34.21(-42.94 to -24.15)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-57.86
2-Sided
95
-72.33
-43.38
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.
This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 Months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00062
OG00157
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.58(-16.79 to 18.78)
OG00119.12(-0.94 to 43.24)
OG002-22.24(-35.45 to -6.32)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-56.33
95
-75.86
-36.81
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months
This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00060
OG00157
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.25(-19.73 to 7.18)
OG00120.91(4.33 to 40.12)
OG002-8.58(-21.33 to 6.24)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
0.004
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-18.28
2-Sided
95
-35.82
-0.74
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months
This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00062
OG00158
OG00257
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.77(-10.39 to 5.49)
OG00142.08(30.64 to 54.52)
OG0028.95(0.10 to 18.60)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-15.57
2-Sided
95
-26.11
-5.04
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months
This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 12 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Base
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00062
OG00157
OG00257
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.91(-8.79 to 18.38)
OG00150.81(31.69 to 72.70)
OG0022.33(-10.63 to 17.16)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-35.74
2-Sided
95
-52.14
-19.33
Secondary
Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months
This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00061
OG00157
OG00259
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.93(-1.86 to -0.01)
OG001-1.44(-2.40 to -0.48)
OG0021.82(0.88 to 2.76)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
4.10
2-Sided
95
2.77
5.42
Secondary
Percentage Change From Baseline in Femoral Neck BMD at 24 Months
Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months
This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00061
OG00157
OG00259
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.85(-1.85 to 0.16)
OG001-1.25(-2.29 to -0.22)
OG0021.97(0.95 to 2.98)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
4.69
2-Sided
95
3.25
6.12
Secondary
Percentage Change From Baseline in Trochanter BMD at 24 Months
Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months
This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00061
OG00157
OG00259
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.81(-2.15 to 0.53)
OG001-0.85(-2.23 to 0.53)
OG0023.61(2.26 to 4.97)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
5.09
2-Sided
95
3.18
7.01
Secondary
Percentage Change From Baseline in Total Body BMD at 24 Months
Percentage change in total body BMD (relative to baseline) at 24 Months
This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00056
OG00147
OG00248
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.54(-2.42 to -0.66)
OG001-2.70(-3.66 to -1.74)
OG002-1.35(-2.29 to -0.40)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least square means
1.73
95
0.46
3.01
Secondary
Percentage Change From Baseline in Distal Forearm BMD at 24 Months
Percentage change in distal forearm BMD (relative to baseline) at 24 Months
This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00061
OG00158
OG00260
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.75(-3.83 to -1.66)
OG001-5.70(-6.80 to -4.59)
OG002-1.22(-2.31 to -0.13)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least square means
2.90
2-Sided
95
1.34
4.46
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months
Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Base
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Base
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Base
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Base
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00056
OG00145
OG00241
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.62(-18.23 to 11.25)
OG00112.89(-4.93 to 34.05)
OG002-40.57(-50.32 to -28.90)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
-47.21
95
-64.51
-29.90
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months
Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00056
OG00145
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG00032.77(13.28 to 55.61)
OG00154.94(29.83 to 84.92)
OG0028.79(-9.35 to 30.57)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
-63.34
95
-88.32
-38.36
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months
Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Geometric LS Mean percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00056
OG00145
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.78(-18.44 to 8.84)
OG00115.96(-1.29 to 36.23)
OG002-7.57(-22.03 to 9.57)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.015
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Square Means
-16.71
95
-36.03
2.61
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months
Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Geometric LS Mean percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00057
OG00147
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.38(-4.94 to 12.44)
OG00140.17(27.80 to 53.73)
OG0022.99(-6.57 to 13.54)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.002
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Square Means
-16.64
95
-28.84
-4.44
Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months
Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Geometric LS Mean percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo-Ext 1
One placebo tablet once a week
OG001
Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
OG002
Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
OG003
Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
OG004
Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00057
OG00147
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.29(-11.11 to 15.43)
OG00150.52(30.37 to 73.79)
OG0029.07(-6.28 to 26.93)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.011
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-21.49
2-Sided
95
-39.55
-3.43
Primary
Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
Percentage change in lumbar spine BMD (relative to baseline) at 36 months
This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.42(-1.89 to 2.73)
OG0012.95(0.79 to 5.11)
OG002-1.57(-3.67 to 0.54)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.
Difference in Least Square Means
6.45
2-Sided
95
3.38
9.53
Superiority or Other
Secondary
Percentage Change From Baseline in Total Hip BMD at 36 Months
Percentage change in total hip BMD (relative to baseline) at 36 months
This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.77(-2.92 to 1.38)
OG0011.16(-0.86 to 3.17)
OG002-0.63(-2.59 to 1.33)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
6.31
2-Sided
95
3.44
9.17
Superiority or Other
Secondary
Percentage Change From Baseline in Femoral Neck BMD at 36 Months
Percentage change in femoral neck BMD (relative to baseline) at 36 Months
This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.52(-2.67 to 1.63)
OG0011.03(-0.98 to 3.04)
OG002-1.04(-2.99 to 0.92)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
2.71
2-Sided
95
-0.16
5.57
Superiority or Other
Secondary
Percentage Change From Baseline in Trochanter BMD at 36 Months
Percentage change in trochanter BMD (relative to baseline) at 36 months
This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.46(-3.71 to 2.79)
OG0012.32(-0.72 to 5.36)
OG002-1.04(-4.00 to 1.92)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
8.13
2-Sided
95
3.80
12.46
Superiority or Other
Secondary
Percentage Change From Baseline in Total Body BMD at 36 Months
Percentage change from baseline in total body BMD (relative to baseline) at 36 Months
This analysis was performed at Month 36 using the Per-Protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00114
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.13(-2.12 to 2.38)
OG001-2.20(-4.45 to 0.05)
OG002-3.63(-5.74 to -1.52)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
1.46
2-Sided
95
-1.54
4.46
Superiority or Other
Secondary
Percentage Change From Baseline in Distal Forearm BMD at 36 Months
Percentage change in distal forearm BMD (relative to baseline) at 36 Months
This analysis was performed at Month 36 using the Per-protocol approach which includes participants who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.
Posted
Least Squares Mean
95% Confidence Interval
Percentage Change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00115
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.08(-4.60 to 0.43)
OG001-4.04(-6.47 to -1.61)
OG002-6.59(-8.95 to -4.23)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
2.47
2-Sided
95
-0.93
5.88
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00115
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG000-17.43(-39.06 to 11.86)
OG001-55.12(-66.51 to 39.85)
OG002-11.90(-35.76 to 20.83)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
-78.06
2-Sided
95
-119.20
-36.92
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00115
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.09(-28.93 to 40.46)
OG001-41.30(-57.74 to -18.47)
OG002-4.69(-33.13 to 35.85)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
-34.25
2-Sided
95
-78.70
10.20
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00115
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG000-18.69(-41.68 to 13.36)
OG001-14.95(-38.27 to 17.18)
OG002-7.82(-34.76 to 30.26)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
-39.25
2-Sided
95
-87.17
8.68
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Geometric Mean Percent Change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.73(-7.32 to 25.24)
OG00110.86(-3.69 to 27.62)
OG00214.26(-1.77 to 32.91)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
16.59
2-Sided
95
-5.67
38.85
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00116
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG000-20.79(-40.08 to 4.72)
OG001-18.79(-37.44 to 5.42)
OG002-13.11(-34.35 to 15.00)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
-5.43
2-Sided
95
-42.04
31.18
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG007
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00010
OG00111
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00052.98(29.87 to 80.21)
OG00152.37(30.34 to 78.12)
OG00233.25(13.12 to 56.97)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Square Means
49.10
2-Sided
95
13.37
84.83
Superiority or Other
Secondary
Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach. Participants with important protocol deviations and major protocol violators were excluded from the analyses. The Per-Protocol approach did not estimate missing data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage change
Baseline and 36 months
ID
Title
Description
OG000
Placebo / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG001
Placebo / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
OG002
Odanacatib 3 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG003
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
OG004
Odanacatib 10 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
OG005
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
OG006
Odanacatib 25 mg / Placebo 50 Mg-Ext 2
12 Month Extension (Year 3)
During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
OG007
Odanacatib 25 mg / 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
OG008
Odanacatib 50 mg / Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
OG009
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
Units
Counts
Participants
OG00014
OG00113
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.40(-16.78 to 38.60)
OG001193.91(125.61 to 282.89)
OG0021.67(-21.41 to 31.53)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG008
OG009
Difference in Least Squares Means
209.44
2-Sided
95
127.14
291.73
Superiority or Other
Primary
Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
Percentage change from baseline in lumbar spine BMD at 60 months.
All participants who took at least one dose of base study medication and at least one dose of extension medication. Missing values were imputed using last observation-carried-forward principle.
Posted
Mean
95% Confidence Interval
Percentage change
Baseline and Month 60
ID
Title
Description
OG000
Placebo Once Weekly
One placebo tablet once a week
OG001
Odanacatib 50 mg Once Weekly
One odanacatib 50 mg tablet once a week
Units
Counts
Participants
OG00014
OG00113
Title
Denominators
Categories
Title
Measurements
OG000-0.41(-3.1 to 2.28)
OG00111.88(7.23 to 16.54)
Primary
Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
Percentage change from baseline in lumbar spine BMD at 120 Months.
This analysis was based on the FAS population, which included all randomized participants who took at least 1 dose of extension study drug and had the necessary extension data available for this endpoint. Missing data were not imputed.
Posted
Mean
95% Confidence Interval
Percentage Change
Baseline and Month 120
ID
Title
Description
OG000
Group A: Odanacatib 50 mg Once Weekly
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
OG001
Group B: Odanacatib 50 mg Once Weekly
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
OG002
Group C: Odanacatib 50 mg Once Weekly
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
OG003
Group D: Odanacatib 50 mg Once Weekly
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
Units
Counts
Participants
OG00020
OG00116
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.92(12.28 to 21.55)
OG00114.56(11.1 to 18.02)
OG00217.18(11.48 to 22.88)
OG003
Primary
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
All participants who received at least 1 administration of the trial drug during treatment years 6-10
Posted
Number
Participants
Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)
ID
Title
Description
OG000
Group A: Odanacatib 50 mg Once Weekly
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
OG001
Group B: Odanacatib 50 mg Once Weekly
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
OG002
Group C: Odanacatib 50 mg Once Weekly
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
OG003
Group D: Odanacatib 50 mg Once Weekly
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
Units
Counts
Participants
OG00028
OG00134
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG00027
OG00134
OG00223
OG003
Primary
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
All participants who received at least 1 administration of the trial drug during treatment years 6-10.
Posted
Number
Participants
Years 6-10 (up to 60 months)
ID
Title
Description
OG000
Group A: Odanacatib 50 mg Once Weekly
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
OG001
Group B: Odanacatib 50 mg Once Weekly
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years
OG002
Group C: Odanacatib 50 mg Once Weekly
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years.
OG003
Group D: Odanacatib 50 mg Once Weekly
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
Units
Counts
Participants
OG00028
OG00134
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0020
OG003
8
83
68
83
EG001
Years 1-2 Odanacatib 3 mg/Odanacatib 3 Mg-Ext 1
One odanacatib 3 mg tablet once a week
12
82
66
82
EG002
Years 1-2 Odanacatib 10 mg/Odanacatib 10 Mg-Ext 1
One odanacatib 10 mg tablet once a week
10
77
67
77
EG003
Years 1-2 Odanacatib 25 mg/Odanacatib 25 Mg-Ext 1
One odanacatib 25 mg tablet once a week
9
79
67
79
EG004
Years 1-2 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 1
One odanacatib 50 mg tablet once a week
14
78
66
78
EG005
Year 3 Placebo/Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
2
19
17
19
EG006
Year 3 Placebo/Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one placebo tablet once a week for 2 years.
2
22
13
22
EG007
Year 3 Odanacatib 3 mg/Placebo-Ext 2
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
3
18
16
18
EG008
Year 3 Odanacatib 3 mg/Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 3 mg tablet of odanacatib once a week for 2 years.
2
17
14
17
EG009
Year 3 Odanacatib 10 mg/Placebo-Ext 2
During this 12-month extension (Year 3), participants took one placebo tablet once a week. Before entering this extension, participants had taken one 10 mg tablet of odanacatib once a week for 2 years.
1
18
13
18
EG010
Year 3 Odanacatib 10 mg/Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group took one 10 mg tablet of odanacatib once a week for 2 years.
1
17
15
17
EG011
Year 3 Odanacatib 25 mg/Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
2
19
15
19
EG012
Year 3 Odanacatib 25 mg/Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 25 mg tablet of odanacatib once a week for 2 years.
3
21
17
21
EG013
Year 3 Odanacatib 50 mg/Placebo-Ext 2
During this 12-month extension (Year 3), participants in this treatment group took one placebo tablet once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
2
18
14
18
EG014
Year 3 Odanacatib 50 mg/Odanacatib 50 Mg-Ext 2
During this 12-month extension (Year 3), participants took one 50 mg tablet of odanacatib once a week. Before entering this extension, participants in this treatment group had taken one 50 mg tablet of odanacatib once a week for 2 years.
1
20
15
20
EG015
Years 4-5 Combined Group A.1: Odanacatib 50 mg
Combined Group A.1 consists of participants who received odanacatib 50 mg once a week during Year 3.
During this 24-month extension (Years 4-5), these participants continued to receive odanacatib 50 mg once a week.
16
73
64
73
EG016
Years 4-5 Combined Group A.2: Odanacatib 50 mg
Combined Group A.2 consists of participants who received placebo or odanacatib 3 mg in Years 1, 2 and 3. During this 24-month extension (Years 4-5), these participants received odanacatib 50 mg once a week.
2
27
24
27
EG017
Years 4-5 Combined Group A.3: Placebo
Combined Group A.3 consists of participants who, during this 24-month extension (Years 4-5), received placebo once a week.
8
41
33
41
EG018
Years 6-10 Group A: Odanacatib 50 mg Once Weekly
Group A consists of a combination of participants who were treated with odanacatib 25 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 50 mg for 10 years.
8
28
25
28
EG019
Years 6-10 Group B: Odanacatib 50 mg Once Weekly
Group B consists of a combination participants who were treated with placebo for 2 years, then odanacatib 50 mg for 8 years; participants who were treated with odanacatib 3 mg for 2 years, then odanacatib 50 mg for 8 years; and participants who were treated with odanacatib 10 mg for 2 years, then odanacatib 50 mg for 8 years.
14
34
31
34
EG020
Years 6-10 Group C: Odanacatib 50 mg Once Weekly
Group C consists of a combination of participants who were treated with placebo for 3 years, then odanacatib 50 mg for 7 years; and participants who were treated with odanacatib 3 mg for 2 years, then placebo for 1 year, then odanacatib 50 mg for 7 years
6
23
23
23
EG021
Years 6-10 Group D: Odanacatib 50 mg Once Weekly
Group D consists of a combination of participants who were treated with odanacatib 10 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; participants who were treated with odanacatib 25 mg for 5 years, then placebo for 3 years, then odanacatib 50 mg for 5 years; and participants who were treated with odanacatib 50 mg for 2 years, then placebo for 3 years, then odanacatib 50 mg for 5 years.
12
32
30
32
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cardiac Failure Congestive
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0034 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Coronary Artery Occlusion
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Myocardial Infarction
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hypoparathyroidism secondary
Endocrine disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Macular Hole
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Retinal Detachment
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Anal Fistula
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Colitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastritis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hiatus Hernia
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Peritonitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Stomatitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Chest Pain
General disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Bronchitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cellulitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0033 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Diverticulitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Ear Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pneumonia
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pneumonia Streptococcal
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Viral Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hip Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Post Procedural Bile Leak
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Electrocardiogram ST-T Change
Investigations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Weight Decreased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0154 events4 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Osteoporotic Fracture
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Anal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0012 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0032 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0072 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0174 events3 affected41 at risk
EG0185 events2 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Breast Cancer In Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Non-Hodgkin's Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Papillary Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Reversible Ischaemic Neurological Deficit
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Syncope
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Nephrolithiasis
Renal and urinary disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Chronic Kidney Disease
Renal and urinary disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Genital Prolapse
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hypertension
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Orthostatic Hypotension
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0192 events2 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cataract
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Respiratory Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Urinary Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Wound Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Head Injury
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Trigger Finger
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Colon Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ovarian Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
VIIth Nerve Paralysis
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cardiac Failure
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Coronary Artery Disease
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tachycardia
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Anal Sphincter Atony
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Flatulence
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Inguinal Hernia
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastroenteritis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pyelonephritis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Sialoadenitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rib Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Colon Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Neurilemmoma Benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Sciatica
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Erythema Nodosum
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Palpitations
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Nausea
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vomiting
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Non-cardiac chest pain
General disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Arthritis bacterial
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Bacterial sepsis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Diverticulitis intestinal haemorrhagic
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0192 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Incarcerated incisional hernia
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Scar
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Urinary retention postoperative
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Cerebral infarction
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Dementia Alzheimer's type
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Headache
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Nerve root compression
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Paraesthesia
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Presyncope
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ovarian cyst
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Ovarian cyst torsion
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Uterine prolapse
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vaginal prolapse
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Hypotension
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events1 affected79 at risk
EG0045 events5 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cataract
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0012 events2 affected82 at risk
EG0024 events4 affected77 at risk
EG0030 events0 affected79 at risk
EG0043 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0113 events2 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0164 events2 affected27 at risk
EG0173 events3 affected41 at risk
EG0180 events0 affected28 at risk
EG0199 events6 affected34 at risk
EG02010 events6 affected23 at risk
EG0211 events1 affected32 at risk
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0015 events5 affected82 at risk
EG0025 events5 affected77 at risk
EG0030 events0 affected79 at risk
EG0047 events5 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0162 events2 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0214 events3 affected32 at risk
Constipation
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events3 affected83 at risk
EG0018 events8 affected82 at risk
EG0027 events6 affected77 at risk
EG0033 events3 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events3 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0183 events2 affected28 at risk
EG0192 events2 affected34 at risk
EG0202 events1 affected23 at risk
EG0211 events1 affected32 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0007 events7 affected83 at risk
EG0015 events4 affected82 at risk
EG0028 events8 affected77 at risk
EG0033 events3 affected79 at risk
EG00410 events7 affected78 at risk
EG0051 events1 affected19 at risk
EG0062 events2 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0143 events3 affected20 at risk
EG0153 events2 affected73 at risk
EG0163 events3 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events2 affected28 at risk
EG0193 events2 affected34 at risk
EG0205 events4 affected23 at risk
EG0212 events2 affected32 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0006 events4 affected83 at risk
EG0013 events2 affected82 at risk
EG0024 events3 affected77 at risk
EG0033 events3 affected79 at risk
EG0045 events5 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events3 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0204 events4 affected23 at risk
EG0213 events3 affected32 at risk
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0013 events3 affected82 at risk
EG0024 events4 affected77 at risk
EG0037 events5 affected79 at risk
EG0043 events3 affected78 at risk
EG0052 events2 affected19 at risk
EG0062 events2 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0153 events3 affected73 at risk
EG0162 events2 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 events2 affected32 at risk
Nausea
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0008 events8 affected83 at risk
EG0016 events4 affected82 at risk
EG0027 events6 affected77 at risk
EG0037 events6 affected79 at risk
EG0047 events5 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0162 events2 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Toothache
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0007 events4 affected83 at risk
EG0014 events3 affected82 at risk
EG0026 events4 affected77 at risk
EG0032 events2 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events4 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Fatigue
General disorders
MedDRA (10.1)
Systematic Assessment
EG0006 events6 affected83 at risk
EG0012 events2 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0043 events3 affected78 at risk
EG0051 events1 affected19 at risk
EG0062 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0153 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Influenza Like Illness
General disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events3 affected83 at risk
EG0011 events1 affected82 at risk
EG0025 events3 affected77 at risk
EG0032 events2 affected79 at risk
EG0047 events6 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Bronchitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0005 events2 affected83 at risk
EG0016 events4 affected82 at risk
EG0025 events4 affected77 at risk
EG0032 events2 affected79 at risk
EG0042 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0063 events2 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0103 events1 affected17 at risk
EG0111 events1 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0157 events4 affected73 at risk
EG0164 events4 affected27 at risk
EG0174 events4 affected41 at risk
EG0184 events3 affected28 at risk
EG0196 events5 affected34 at risk
EG0209 events5 affected23 at risk
EG0215 events5 affected32 at risk
Cystitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0003 events1 affected83 at risk
EG0016 events6 affected82 at risk
EG0023 events3 affected77 at risk
EG0032 events1 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0142 events2 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0202 events2 affected23 at risk
EG0210 events0 affected32 at risk
Gastroenteritis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0004 events3 affected83 at risk
EG0013 events2 affected82 at risk
EG0021 events1 affected77 at risk
EG0034 events4 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0072 events2 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0162 events2 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Pharyngitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0012 events2 affected82 at risk
EG0024 events4 affected77 at risk
EG0032 events2 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0112 events2 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0202 events1 affected23 at risk
EG0211 events1 affected32 at risk
Sinusitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0014 events4 affected82 at risk
EG0026 events5 affected77 at risk
EG0035 events4 affected79 at risk
EG0046 events5 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0072 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0092 events2 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0153 events3 affected73 at risk
EG0165 events3 affected27 at risk
EG0172 events2 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events1 affected34 at risk
EG0204 events4 affected23 at risk
EG0210 events0 affected32 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG00011 events9 affected83 at risk
EG00112 events10 affected82 at risk
EG0029 events7 affected77 at risk
EG00311 events7 affected79 at risk
EG00414 events10 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0074 events3 affected18 at risk
EG0082 events2 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0123 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events3 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0187 events2 affected28 at risk
EG0195 events3 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 affected32 at risk
Urinary Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG00017 events11 affected83 at risk
EG0017 events6 affected82 at risk
EG0027 events7 affected77 at risk
EG00310 events8 affected79 at risk
EG00415 events12 affected78 at risk
EG0051 events1 affected19 at risk
EG0063 events2 affected22 at risk
EG0071 events1 affected18 at risk
EG0082 events2 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0123 events3 affected21 at risk
EG0130 events0 affected18 at risk
EG0143 events2 affected20 at risk
EG01512 events10 affected73 at risk
EG0164 events4 affected27 at risk
EG0173 events2 affected41 at risk
EG01815 events9 affected28 at risk
EG01919 events9 affected34 at risk
EG02020 events6 affected23 at risk
EG02115 events7 affected32 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0005 events5 affected83 at risk
EG0014 events2 affected82 at risk
EG0028 events5 affected77 at risk
EG0033 events2 affected79 at risk
EG0043 events3 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0082 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0156 events4 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG0183 events3 affected28 at risk
EG0190 events0 affected34 at risk
EG0202 events1 affected23 at risk
EG0217 events3 affected32 at risk
Alanine Aminotransferase Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0014 events3 affected82 at risk
EG0020 events0 affected77 at risk
EG0037 events5 affected79 at risk
EG0043 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0204 events4 affected23 at risk
EG0213 events3 affected32 at risk
Aspartate Aminotransferase Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0015 events3 affected82 at risk
EG0022 events2 affected77 at risk
EG0036 events4 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0204 events4 affected23 at risk
EG0212 events2 affected32 at risk
Weight Decreased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0044 events4 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events2 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 events2 affected32 at risk
Weight Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0012 events2 affected82 at risk
EG0023 events3 affected77 at risk
EG0036 events5 affected79 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG00024 events13 affected83 at risk
EG00116 events12 affected82 at risk
EG00213 events12 affected77 at risk
EG00317 events14 affected79 at risk
EG00414 events12 affected78 at risk
EG0054 events3 affected19 at risk
EG0061 events1 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected18 at risk
EG0102 events1 affected17 at risk
EG0112 events2 affected19 at risk
EG0124 events3 affected21 at risk
EG0130 events0 affected18 at risk
EG0144 events3 affected20 at risk
EG01513 events9 affected73 at risk
EG0164 events4 affected27 at risk
EG0178 events6 affected41 at risk
EG01810 events5 affected28 at risk
EG0194 events4 affected34 at risk
EG0208 events8 affected23 at risk
EG0213 events3 affected32 at risk
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0017 events7 affected82 at risk
EG0027 events7 affected77 at risk
EG0033 events3 affected79 at risk
EG00416 events13 affected78 at risk
EG0051 events1 affected19 at risk
EG0063 events2 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0142 events2 affected20 at risk
EG0153 events3 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0202 events2 affected23 at risk
EG0211 events1 affected32 at risk
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0005 events5 affected83 at risk
EG0013 events3 affected82 at risk
EG0025 events5 affected77 at risk
EG00311 events10 affected79 at risk
EG0044 events4 affected78 at risk
EG0052 events2 affected19 at risk
EG0061 events1 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0123 events3 affected21 at risk
EG0132 events2 affected18 at risk
EG0140 events0 affected20 at risk
EG0155 events4 affected73 at risk
EG0161 events1 affected27 at risk
EG0176 events6 affected41 at risk
EG0186 events3 affected28 at risk
EG0194 events4 affected34 at risk
EG0206 events5 affected23 at risk
EG0214 events4 affected32 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events3 affected83 at risk
EG0012 events2 affected82 at risk
EG0024 events4 affected77 at risk
EG0034 events3 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0202 events2 affected23 at risk
EG0210 events0 affected32 at risk
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events3 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0035 events5 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0122 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0144 events4 affected20 at risk
EG0153 events3 affected73 at risk
EG0162 events2 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0194 events3 affected34 at risk
EG0204 events3 affected23 at risk
EG0211 events1 affected32 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0015 events5 affected82 at risk
EG0025 events4 affected77 at risk
EG0034 events4 affected79 at risk
EG0045 events5 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0092 events2 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0123 events3 affected21 at risk
EG0132 events1 affected18 at risk
EG0141 events1 affected20 at risk
EG0157 events6 affected73 at risk
EG0163 events2 affected27 at risk
EG0172 events1 affected41 at risk
EG0183 events3 affected28 at risk
EG0196 events5 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 events2 affected32 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0016 events6 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0182 events2 affected28 at risk
EG0193 events3 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 events2 affected32 at risk
Dizziness
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0005 events4 affected83 at risk
EG0019 events7 affected82 at risk
EG00210 events8 affected77 at risk
EG0033 events3 affected79 at risk
EG0044 events4 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0133 events2 affected18 at risk
EG0141 events1 affected20 at risk
EG0153 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events2 affected28 at risk
EG0193 events3 affected34 at risk
EG0202 events2 affected23 at risk
EG0212 events2 affected32 at risk
Headache
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG00013 events11 affected83 at risk
EG0019 events9 affected82 at risk
EG00210 events10 affected77 at risk
EG00310 events9 affected79 at risk
EG00412 events9 affected78 at risk
EG0050 events0 affected19 at risk
EG0062 events2 affected22 at risk
EG0071 events1 affected18 at risk
EG0083 events3 affected17 at risk
EG0091 events1 affected18 at risk
EG0101 events1 affected17 at risk
EG0111 events1 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0141 events1 affected20 at risk
EG0152 events2 affected73 at risk
EG0162 events2 affected27 at risk
EG0172 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0193 events2 affected34 at risk
EG0204 events3 affected23 at risk
EG0214 events3 affected32 at risk
Depression
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0005 events5 affected83 at risk
EG0014 events4 affected82 at risk
EG0025 events5 affected77 at risk
EG0033 events3 affected79 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0062 events2 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0163 events3 affected27 at risk
EG0171 events1 affected41 at risk
EG0183 events3 affected28 at risk
EG0195 events4 affected34 at risk
EG0204 events2 affected23 at risk
EG0212 events2 affected32 at risk
Insomnia
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0007 events7 affected83 at risk
EG0014 events3 affected82 at risk
EG0024 events4 affected77 at risk
EG0033 events3 affected79 at risk
EG0046 events6 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG0182 events2 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0013 events3 affected82 at risk
EG0023 events3 affected77 at risk
EG0035 events5 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events3 affected73 at risk
EG0161 events1 affected27 at risk
EG0172 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0212 events1 affected32 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG00010 events7 affected83 at risk
EG0014 events4 affected82 at risk
EG0026 events5 affected77 at risk
EG0032 events2 affected79 at risk
EG0043 events3 affected78 at risk
EG0052 events2 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0132 events2 affected18 at risk
EG0143 events1 affected20 at risk
EG0152 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0192 events2 affected34 at risk
EG0202 events2 affected23 at risk
EG0210 events0 affected32 at risk
Hypertension
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0017 events7 affected82 at risk
EG0023 events3 affected77 at risk
EG0038 events8 affected79 at risk
EG0044 events4 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0112 events2 affected19 at risk
EG0120 events0 affected21 at risk
EG0132 events2 affected18 at risk
EG0140 events0 affected20 at risk
EG0156 events5 affected73 at risk
EG0162 events2 affected27 at risk
EG0172 events2 affected41 at risk
EG0183 events3 affected28 at risk
EG0197 events6 affected34 at risk
EG0205 events5 affected23 at risk
EG0213 events3 affected32 at risk
Arrhythmia
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Atrial Flutter
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Mitral Valve Prolapse
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tachycardia
Cardiac disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Deafness
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events2 affected34 at risk
EG0202 events2 affected23 at risk
EG0210 events0 affected32 at risk
Tympanosclerosis
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vertigo
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0005 events4 affected83 at risk
EG0010 events0 affected82 at risk
EG0023 events3 affected77 at risk
EG0031 events1 affected79 at risk
EG0043 events3 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0092 events2 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0197 events5 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Vertigo Positional
Ear and labyrinth disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hypothyroidism
Endocrine disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 affected32 at risk
Thyroiditis Chronic
Endocrine disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Conjunctivitis Allergic
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Eye Pruritus
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Macular Degeneration
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0034 events2 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0102 events2 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0173 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0213 events2 affected32 at risk
Anal Fissure
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Aphthous Ulcer
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Dry Mouth
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0012 events2 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Duodenal Ulcer
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Faecal Incontinence
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Flatulence
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0032 events2 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastric Disorder
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastric Polyps
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastric Ulcer
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Gastritis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0013 events3 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0142 events2 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Gingival Swelling
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Inguinal Hernia
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0092 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Irritable Bowel Syndrome
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0023 events3 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0083 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Mouth Ulceration
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0102 events1 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events3 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0034 events2 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Vomiting
Gastrointestinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0023 events3 affected77 at risk
EG0034 events4 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Calcinosis
General disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Chest Discomfort
General disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0013 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events2 affected79 at risk
EG0042 events2 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Chest Pain
General disorders
MedDRA (10.1)
Systematic Assessment
EG0008 events4 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0032 events2 affected79 at risk
EG0043 events3 affected78 at risk
EG0052 events2 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0183 events2 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Oedema Peripheral
General disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events3 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0032 events2 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0101 events1 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0143 events3 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0203 events2 affected23 at risk
EG0210 events0 affected32 at risk
Allergy To Arthropod Sting
Immune system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Bacterial Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Cellulitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Chronic Sinusitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ear Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0014 events2 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Eye Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events2 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0212 events2 affected32 at risk
Fungal Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Furuncle
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Herpes Zoster
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Influenza
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0013 events3 affected82 at risk
EG0021 events1 affected77 at risk
EG0032 events2 affected79 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events4 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0194 events4 affected34 at risk
EG0200 events0 affected23 at risk
EG0217 events5 affected32 at risk
Nasal Abscess
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0052 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Nasopharyngitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG00020 events14 affected83 at risk
EG00113 events9 affected82 at risk
EG00220 events16 affected77 at risk
EG00310 events8 affected79 at risk
EG00423 events14 affected78 at risk
EG0051 events1 affected19 at risk
EG0065 events4 affected22 at risk
EG0073 events2 affected18 at risk
EG0082 events2 affected17 at risk
EG0093 events3 affected18 at risk
EG0100 events0 affected17 at risk
EG0112 events2 affected19 at risk
EG0123 events3 affected21 at risk
EG0131 events1 affected18 at risk
EG0142 events1 affected20 at risk
EG01516 events13 affected73 at risk
EG01613 events6 affected27 at risk
EG01713 events10 affected41 at risk
EG0189 events7 affected28 at risk
EG01915 events8 affected34 at risk
EG0209 events5 affected23 at risk
EG02120 events9 affected32 at risk
Onychomycosis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0052 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0152 events2 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events2 affected34 at risk
EG0204 events3 affected23 at risk
EG0212 events1 affected32 at risk
Oral Candidiasis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Oral Herpes
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events2 affected79 at risk
EG0045 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0141 events1 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events2 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0212 events1 affected32 at risk
Otitis Media Acute
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Pharyngitis Streptococcal
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pneumonia
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0173 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0214 events3 affected32 at risk
Pyoderma
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Respiratory Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0082 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0202 events1 affected23 at risk
EG0210 events0 affected32 at risk
Respiratory Tract Infection Viral
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rhinitis
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0013 events3 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events2 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tooth Abscess
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0032 events2 affected79 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tooth Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0033 events3 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Viral Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0002 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0034 events4 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA (10.1)
Systematic Assessment
EG0002 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0013 events3 affected82 at risk
EG0022 events2 affected77 at risk
EG0032 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Arthropod Sting
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0172 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Epicondylitis
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0182 events2 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0003 events2 affected83 at risk
EG0012 events2 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0132 events2 affected18 at risk
EG0140 events0 affected20 at risk
EG0154 events3 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG01813 events3 affected28 at risk
EG0198 events4 affected34 at risk
EG0206 events5 affected23 at risk
EG0219 events4 affected32 at risk
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0092 events1 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0004 events4 affected83 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected77 at risk
EG0033 events3 affected79 at risk
EG0045 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0062 events2 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Limb Injury
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0092 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Muscle Strain
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0035 events4 affected79 at risk
EG0042 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Wound
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Procedural Pain
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0012 events2 affected82 at risk
EG0023 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0043 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0102 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Radius Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0162 events2 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0062 events2 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Skull Fractured Base
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Blood 1,25-Dihydroxycholecalciferol Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0052 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Blood Cholesterol Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0102 events2 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Blood Glucose Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0033 events2 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 affected32 at risk
Blood Parathyroid Hormone Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0052 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0071 events1 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0105 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG01513 events5 affected73 at risk
EG0165 events3 affected27 at risk
EG0173 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Blood Pressure Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events2 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Blood Triglycerides Increased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Carotid Bruit
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Glucose Urine Present
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
High Density Lipoprotein Decreased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Lymphocyte Count Decreased
Investigations
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0043 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0133 events3 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
White Blood Cells Urine Positive
Investigations
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0013 events2 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0042 events2 affected78 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0013 events3 affected82 at risk
EG0021 events1 affected77 at risk
EG0033 events3 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0072 events2 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0162 events2 affected27 at risk
EG0170 events0 affected41 at risk
EG0183 events3 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0214 events4 affected32 at risk
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG00012 events10 affected83 at risk
EG00119 events17 affected82 at risk
EG00211 events9 affected77 at risk
EG00319 events14 affected79 at risk
EG00413 events11 affected78 at risk
EG0052 events2 affected19 at risk
EG0065 events5 affected22 at risk
EG0071 events1 affected18 at risk
EG0082 events2 affected17 at risk
EG0091 events1 affected18 at risk
EG0101 events1 affected17 at risk
EG0115 events4 affected19 at risk
EG0122 events2 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG01511 events8 affected73 at risk
EG0167 events5 affected27 at risk
EG0171 events1 affected41 at risk
EG0186 events6 affected28 at risk
EG0199 events7 affected34 at risk
EG0207 events5 affected23 at risk
EG0212 events2 affected32 at risk
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0012 events2 affected82 at risk
EG0023 events3 affected77 at risk
EG0033 events3 affected79 at risk
EG0042 events2 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0083 events2 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0152 events2 affected73 at risk
EG0162 events2 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0212 events2 affected32 at risk
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Dupuytren's Contracture
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0072 events2 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Joint Stiffness
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Muscle Contracture
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0062 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0192 events2 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0033 events3 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0213 events3 affected32 at risk
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0122 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Osteochondritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Osteosclerosis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0112 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG00013 events10 affected83 at risk
EG00110 events8 affected82 at risk
EG0028 events8 affected77 at risk
EG00311 events11 affected79 at risk
EG0045 events3 affected78 at risk
EG0051 events1 affected19 at risk
EG0064 events3 affected22 at risk
EG0071 events1 affected18 at risk
EG0082 events2 affected17 at risk
EG0093 events3 affected18 at risk
EG0101 events1 affected17 at risk
EG0114 events3 affected19 at risk
EG0122 events2 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG01515 events12 affected73 at risk
EG0165 events4 affected27 at risk
EG0172 events2 affected41 at risk
EG0186 events6 affected28 at risk
EG0191 events1 affected34 at risk
EG0203 events2 affected23 at risk
EG0219 events7 affected32 at risk
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0025 events3 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Synovial Cyst
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Ovarian Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Memory Impairment
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Migraine
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Paraesthesia
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0141 events1 affected20 at risk
EG0153 events3 affected73 at risk
EG0161 events1 affected27 at risk
EG0173 events2 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Sciatica
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events2 affected83 at risk
EG0014 events2 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0082 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0153 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Somnolence
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tension Headache
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0021 events1 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Tremor
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events1 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0102 events2 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Trigeminal Neuralgia
Nervous system disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Alcoholism
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Anxiety
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0023 events3 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0052 events2 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Dysthymic Disorder
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Stress
Psychiatric disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Breast Mass
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Fibrocystic Breast Disease
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pelvic Pain
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Vulvovaginal Discomfort
Reproductive system and breast disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0032 events2 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0213 events1 affected32 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0004 events2 affected83 at risk
EG0012 events2 affected82 at risk
EG0025 events2 affected77 at risk
EG0034 events3 affected79 at risk
EG0043 events3 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0102 events2 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0141 events1 affected20 at risk
EG0154 events4 affected73 at risk
EG0160 events0 affected27 at risk
EG0173 events3 affected41 at risk
EG0180 events0 affected28 at risk
EG0192 events2 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0193 events3 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0041 events1 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (10.1)
Systematic Assessment
EG0002 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Actinic Keratosis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0022 events2 affected77 at risk
EG0032 events2 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0171 events1 affected41 at risk
EG0181 events1 affected28 at risk
EG0192 events2 affected34 at risk
EG0200 events0 affected23 at risk
EG0214 events3 affected32 at risk
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0203 events2 affected23 at risk
EG0211 events1 affected32 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Granuloma Annulare
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0170 events0 affected41 at risk
EG0181 events1 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Lichen Planus
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0022 events2 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0152 events1 affected73 at risk
EG0161 events1 affected27 at risk
EG0171 events1 affected41 at risk
EG0182 events2 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0003 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0131 events1 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Sebaceous Hyperplasia
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0111 events1 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0001 events1 affected83 at risk
EG0010 events0 affected82 at risk
EG0023 events3 affected77 at risk
EG0033 events2 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0161 events1 affected27 at risk
EG0172 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0200 events0 affected23 at risk
EG0211 events1 affected32 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events2 affected79 at risk
EG0040 events0 affected78 at risk
EG0053 events1 affected19 at risk
EG0061 events1 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events1 affected41 at risk
EG0180 events0 affected28 at risk
EG0191 events1 affected34 at risk
EG0202 events1 affected23 at risk
EG0210 events0 affected32 at risk
Flushing
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0101 events1 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Haematoma
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected77 at risk
EG0031 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0082 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0121 events1 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0153 events2 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
Phlebitis
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0071 events1 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0200 events0 affected23 at risk
EG0210 events0 affected32 at risk
Varicose Vein
Vascular disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0032 events1 affected79 at risk
EG0040 events0 affected78 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0151 events1 affected73 at risk
EG0160 events0 affected27 at risk
EG0172 events2 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0211 events1 affected32 at risk
Eyelid Ptosis
Eye disorders
MedDRA (10.1)
Systematic Assessment
EG0000 events0 affected83 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected77 at risk
EG0030 events0 affected79 at risk
EG0040 events0 affected78 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected18 at risk
EG0081 events1 affected17 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected17 at risk
EG0110 events0 affected19 at risk
EG0120 events0 affected21 at risk
EG0130 events0 affected18 at risk
EG0140 events0 affected20 at risk
EG0150 events0 affected73 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected41 at risk
EG0180 events0 affected28 at risk
EG0190 events0 affected34 at risk
EG0201 events1 affected23 at risk
EG0210 events0 affected32 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
D009750
Nutritional and Metabolic Diseases
D011083
Polycyclic Compounds
D013261
Sterols
D014807
Vitamin D
D012632
Secosteroids
D008563
Membrane Lipids
D008055
Lipids
D017610
Calcium Compounds
D007287
Inorganic Chemicals
D002254
Carbonates
D002255
Carbonic Acid
D017554
Carbon Compounds, Inorganic
D008903
Minerals
0 subjects
FG0051 subjects
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0 subjects
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FG0200 subjects
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FG0250 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
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FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
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FG0240 subjects
FG0250 subjects
0 subjects
FG0050 subjects
FG0060 subjects
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FG0080 subjects
FG0090 subjects
FG0100 subjects
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FG0160 subjects
FG0170 subjects
FG0182 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
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FG0200 subjects
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0 subjects
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0 subjects
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0
BG0050
65
OG00458
4.26
(3.35 to 5.18)
OG0045.48(4.52 to 6.44)
Superiority or Other
OG000
OG003
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
4.45
2-Sided
95
3.15
5.76
Superiority or Other
OG000
OG002
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Squares Means
3.39
2-Sided
95
2.06
4.73
Superiority or Other
OG000
OG001
The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.218
Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.
Difference in Least Square Means
-0.84
95
-2.19
0.51
Superiority or Other
78
OG00477
1.45
(0.84 to 2.07)
OG0041.87(1.25 to 2.49)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
2.06
2-Sided
95
1.20
2.93
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
1.67
2-Sided
95
0.80
2.53
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.135
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-0.75
2-Sided
95
-1.61
0.11
Superiority or Other
78
OG00477
1.76
(1.08 to 2.44)
OG0042.53(1.85 to 3.21)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
1.89
2-Sided
95
0.93
2.84
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.095
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
0.87
2-Sided
95
-0.09
1.82
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Difference in Least Squares Means
-0.19
2-Sided
95
-1.14
0.75
Superiority or Other
78
OG00477
1.91
(0.99 to 2.84)
OG0042.21(1.28 to 3.14)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
2.65
2-Sided
95
1.35
3.94
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
2.38
2-Sided
95
1.08
3.69
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.731
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-0.29
2-Sided
95
-1.58
1.00
Superiority or Other
75
OG00470
-0.51
(-1.23 to 0.22)
OG004-0.13(-0.89 to 0.62)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-0.09
2-Sided
95
-1.13
0.95
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-0.63
2-Sided
95
-1.69
0.42
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-1.47
2-Sided
95
-2.53
-0.42
Superiority or Other
78
OG00477
-0.17
(-0.89 to 0.55)
OG004-0.04(-0.77 to 0.68)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.005
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
1.10
2-Sided
95
0.09
2.11
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.630
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
0.27
2-Sided
95
-0.74
1.29
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-1.27
2-Sided
95
-2.28
-0.27
Superiority or Other
63
OG00456
-48.29
(-54.80 to -40.84)
OG004-60.23(-65.51 to -54.13)
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-45.92
2-Sided
95
-60.93
-30.91
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
-31.84
2-Sided
95
-48.11
-15.58
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
0.249
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
11.17
2-Sided
95
-0.94
43.24
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
62
OG00455
-36.15
(-46.54 to -23.75)
OG004-56.91(-64.31 to -47.99)
Difference in Least Squares Means (back-transformation from difference in log-fraction)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Square Means
-35.57
95
-56.63
-14.51
Difference in Least Square Means (back-transformation from difference in log-fraction)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
0.080
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-21.66
95
-44.54
1.23
Difference in Least Squares Means (back-transformation from difference in log-fraction)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
19.70
2-Sided
95
-8.48
47.88
Difference in Least Squares Means (back-transformation from difference in log-fraction)
Superiority or Other
63
OG00455
-8.50
(-20.52 to 5.33)
OG004-25.52(-35.93 to -13.43)
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
0.344
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-1.26
2-Sided
95
-19.90
17.39
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-1.33
2-Sided
95
-20.55
17.89
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
28.15
2-Sided
95
5.84
50.46
Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
64
OG00458
2.66
(-5.25 to 11.24)
OG004-18.35(-24.93 to -11.18)
Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.645
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
5.43
2-Sided
95
-6.02
16.89
Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
11.73
2-Sided
95
-0.47
23.92
Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
44.85
2-Sided
95
30.55
59.16
Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)
Superiority or Other
63
OG00458
2.23
(-10.12 to 16.28)
OG004-31.83(-40.40 to -22.02)
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.161
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-1.68
2-Sided
95
-20.58
17.23
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
-1.58
2-Sided
95
-20.99
17.82
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
46.90
2-Sided
95
22.35
71.44
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
65
OG00458
2.55
(1.66 to 3.44)
OG0043.16(2.22 to 4.11)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Squares Means
3.48
2-Sided
95
2.20
4.77
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
2.75
2-Sided
95
1.43
4.07
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.536
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-0.51
2-Sided
95
-1.84
0.83
Superiority or Other
65
OG00458
2.73
(1.76 to 3.69)
OG0043.84(2.82 to 4.86)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
3.57
2-Sided
95
2.18
4.97
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
2.82
2-Sided
95
1.39
4.25
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.585
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-0.41
2-Sided
95
-1.85
1.04
Superiority or Other
65
OG00458
3.75
(2.46 to 5.04)
OG0044.28(2.92 to 5.65)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
4.56
2-Sided
95
2.70
6.42
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
4.43
2-Sided
95
2.52
6.33
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.981
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-0.04
2-Sided
95
-1.97
1.89
Superiority or Other
58
OG00451
-0.43
(-1.29 to 0.43)
OG0040.19(-0.73 to 1.11)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.028
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least square means
1.11
95
-0.12
2.34
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.804
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least square means
0.20
95
-1.10
1.49
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least square means
-1.15
2-Sided
95
-2.46
0.15
Superiority or Other
65
OG00457
-0.65
(-1.70 to 0.39)
OG0040.15(-0.97 to 1.27)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least square means
2.09
95
0.59
3.60
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
0.094
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least square means
1.53
95
-0.01
3.07
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least square means
-2.95
95
-4.50
-1.40
Superiority or Other
51
OG00438
-38.30
(-47.48 to -27.51)
OG004-51.83(-60.05 to -41.91)
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
-33.67
95
-51.44
-15.91
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Square Means
-35.94
95
-54.15
-17.74
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.101
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.
Difference in Least Squares Means
17.51
2-Sided
95
-6.78
41.80
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
52
OG00439
-6.52
(-20.70 to 10.19)
OG004-30.57(-42.60 to -16.20)
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
<=0.001
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-39.29
2-Sided
95
-65.40
-13.18
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.124
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.
Difference in Least Squares Means
-23.98
2-Sided
95
-53.04
5.09
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Squares Means
22.18
2-Sided
95
-12.38
56.73
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
51
OG00438
-14.30
(-26.30 to -0.33)
OG004-22.49(-34.96 to -7.64)
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.246
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Square Means
-8.51
95
-27.31
10.29
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Square Means
-1.79
95
-22.66
19.08
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Square Means
21.74
95
-1.32
44.81
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).
Superiority or Other
53
OG00442
10.62
(1.40 to 20.69)
OG004-13.62(-21.36 to -4.32)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.852
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least Square Means
7.24
95
-5.73
20.21
Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Square Means
-0.39
95
-13.69
12.92
Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Square Means
36.79
95
21.19
52.38
Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)
Superiority or Other
53
OG00442
14.60
(0.08 to 31.23)
OG004-20.20(-31.49 to -7.05)
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG003
The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
0.618
Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure
Difference in Least square means
13.31
95
-7.10
33.71
Difference in Least square means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG002
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least square means
7.77
2-Sided
95
-13.46
29.01
Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)
Superiority or Other
OG000
OG001
The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.
ANCOVA
Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.
Difference in Least Square Means
49.23
2-Sided
95
23.86
74.59
Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)