A Study of LY2541546 in Women With Low Bone Mineral Density | NCT01144377 | Trialant
NCT01144377
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 17, 2019Actual
Enrollment
154Actual
Phase
Phase 2
Conditions
Osteoporosis
Interventions
LY2541546
Placebo
Countries
United States
Denmark
Estonia
Japan
Lithuania
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
NCT01144377
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11953
Secondary IDs
ID
Type
Description
Link
I2M-MC-GSDB
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2541546 in Women With Low Bone Mineral Density
Official Title
A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 2019
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
Aug 2010
Primary Completion Date
May 2012Actual
Completion Date
Feb 2013Actual
First Submitted Date
Jun 11, 2010
First Submission Date that Met QC Criteria
Jun 11, 2010
First Posted Date
Jun 15, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Oct 28, 2017
Results First Posted Date
Dec 4, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 18, 2012
Certification/Extension First Submitted that Passed QC Review
Sep 18, 2012
Certification/Extension First Posted Date
Sep 25, 2012Estimated
Last Update Submitted Date
Sep 9, 2019
Last Update Posted Date
Sep 17, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participants will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).
Detailed Description
Not provided
Conditions Module
Conditions
Osteoporosis
Keywords
osteoporosis
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
154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
180 mg LY2541546 Q4W + Placebo
Experimental
LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.
Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
Drug: LY2541546
Drug: Placebo
180 mg LY2541546 Q2W
Experimental
LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Drug: LY2541546
270 mg LY2541546 Q2W
Experimental
LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Drug: LY2541546
270 mg LY2541546 Q12W + Placebo
Experimental
LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.
Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
Drug: LY2541546
Drug: Placebo
Placebo Comparator Q2W
Placebo Comparator
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2541546
Drug
Administered subcutaneously
180 mg LY2541546 Q2W
180 mg LY2541546 Q4W + Placebo
270 mg LY2541546 Q12W + Placebo
270 mg LY2541546 Q2W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Baseline, 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ambulatory, postmenopausal women, inclusive.
Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter [g/cm^2]) for the lumbar spine of between -3.5 and -2.0, inclusive.
Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
Willing to take study drug and daily supplements (calcium and Vitamin D).
Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits, and platelet level greater than 100,000 cubic millimeters (mm^3).
Exclusion Criteria:
Have received treatment with any of the following medications more recently than 3 months prior to screening Androgen, Calcitonin, Estrogen (including over the counter preparations known to have estrogenic activity), Progestin (including over the counter preparations known to have progestogenic activity), selective estrogen receptor modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or Tibolone.
Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
Have received treatment with any oral bisphosphonate within the last year.
Have received therapeutic doses of systemic corticosteroids for more than one month during the 6 months prior to screening.
Have received therapeutic doses of fluorides (20 milligrams per day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months.
Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <9.2 nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/L)] at screening. If the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL and <20 ng/mL, participants will receive a loading dose of Vitamin D (at a dose of approximately 100,000 international units (IU) given orally) prior to enrollment.
Have any known bone disorder other than low BMD or osteoporosis.
Have a history of osteoporotic fractures, including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.
Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA evaluation of lumbar vertebrae in the L-1 through L-4 region.
Have a history of Bell's palsy, other cranial nerve disorders, or have a history of Temporomandibular Joint and Muscle Disorders (TMJDs).
Have any history of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data.
Have acute or chronic liver disease ([bilirubin >34 micromoles per liter (µmol/L) or >2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per liter (U/L), or alkaline phosphatase >300 U/L)].
Have impaired kidney function serum creatinine >135 µmol/L or >2.0 mg/dL.
Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody.
History of excessive consumption of alcohol or abuse of drugs within the last year.
Have poor medical condition or psychiatric risks for treatment with an investigational drug.
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
45 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville
Georgia
30501
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
FG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
FG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
FG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period for an additional 40 weeks (for a total of 52 weeks follow-up for the main study participants only).
FG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. After exposure to study medication for the 52 week treatment phase, participants entered a 12 week non-treatment safety follow-up period with the option of staying in the non-treatment safety follow-up period (for an additional 40 weeks for a total of 52 weeks follow-up for the main study participants only).
Periods
Title
Milestones
Reasons Not Completed
52 Week Treatment Period
Type
Comment
Milestone Data
STARTED
FG00031 subjects
FG00130 subjects
FG00230 subjects
FG00326 subjects
FG00437 subjects
Received at Least One Dose of Study Drug
FG00031 subjects
FG00130 subjects
FG00230 subjects
FG00325 subjects
COMPLETED
FG00026 subjects
FG00129 subjects
FG00225 subjects
FG00322 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG003
12 Week Safety Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00026 subjects
FG00129 subjects
FG00225 subjects
FG003
Optional 40 Week Safety Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00022 subjects
FG00125 subjects
FG00223 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
BG001
180 mg LY2541546 Q2W
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
Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered every alternate 2 weeks from the LY2541546 dose for 52 weeks.
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
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
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA 16.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
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
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
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
C000593189
blosozumab
Ancestor Terms
Not provided
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
Drug: Placebo
Blosozumab
Placebo
Drug
Administered subcutaneously
180 mg LY2541546 Q4W + Placebo
270 mg LY2541546 Q12W + Placebo
Placebo Comparator Q2W
Baseline, 12 weeks and 24 weeks and 64 weeks
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.
Baseline, 24 weeks and 52 weeks and 64 weeks
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.
Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Osteocalcin
Baseline, 52 weeks
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
Baseline, 52 weeks
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda
Maryland
20817
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hvidovre
2650
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vejle
7100
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn
10128
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagano
386-0493
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo
166-0003
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vilnius
10323
Lithuania
FG004
37 subjects
34 subjects
3 subjects
2 subjects
FG0041 subjects
Entry Criteria Not Met
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
22 subjects
FG00434 subjects
COMPLETED
FG00026 subjectsOf the 26 participants who completed this Period, 22 continued to the Optional 40 Week follow-up.
FG00129 subjectsOf the 29 participants who completed this Period, 25 continued to the Optional 40 Week follow-up.
FG00225 subjectsOf the 25 participants who completed this Period, 23 continued to the Optional 40 Week follow-up.
FG00322 subjectsOf the 22 participants who completed this Period, 3 continued to the Optional 40 Week follow-up.
FG00434 subjectsOf the 34 participants who completed this Period, 23 continued to the Optional 40 Week follow-up.
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
3 subjects
FG00423 subjects
COMPLETED
FG00021 subjects
FG00124 subjects
FG00223 subjects
FG0033 subjects
FG00421 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
BG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
BG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
BG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
BG005
Total
Total of all reporting groups
31
BG00130
BG00230
BG00325
BG00437
BG005153
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.78± 8.98
BG00164.17± 8.20
BG00266.12± 7.68
BG00363.56± 8.02
BG00465.17± 8.91
BG00565.22± 8.38
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00031
BG00130
BG00230
BG00325
BG00437
BG005153
Male
BG0000
BG0010
BG0020
BG0030
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG0022
BG0039
BG0048
BG00527
Not Hispanic or Latino
BG00023
BG00124
BG00226
BG00316
BG004
Unknown or Not Reported
BG0004
BG0012
BG0022
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Asian
BG00014
BG00113
BG00213
BG00311
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG00017
BG00117
BG00217
BG00314
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0016
BG0025
BG00311
BG00410
BG00536
Estonia
Title
Measurements
BG0004
BG0013
BG0025
BG003
Lithuania
Title
Measurements
BG0003
BG0014
BG0024
BG003
Denmark
Title
Measurements
BG0006
BG0014
BG0023
BG003
Japan
Title
Measurements
BG00014
BG00113
BG00213
BG003
Lumbar Spine Bone Mineral Density (Baseline)
Mean
Standard Deviation
grams/square centimeter (g/cm^2)
Title
Denominators
Categories
Title
Measurements
BG0000.78± 0.09
BG0010.78± 0.07
BG0020.80± 0.09
BG0030.77± 0.09
BG0040.78± 0.09
BG0050.78± 0.09
Femoral Neck Bone Mineral Density (Baseline)
Mean
Standard Deviation
g/cm^2
Title
Denominators
Categories
Title
Measurements
BG0000.66± 0.15
BG0010.66± 0.15
BG0020.69± 0.11
BG0030.63± 0.11
BG0040.66± 0.17
BG0050.66± 0.14
Total Hip Bone Mineral Density (Baseline)
Mean
Standard Deviation
grams/square centimeter
Title
Denominators
Categories
Title
Measurements
BG0000.75± 0.11
BG0010.75± 0.13
BG0020.77± 0.10
BG0030.73± 0.11
BG0040.73± 0.14
BG0050.75± 0.12
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00027
OG00129
OG00226
OG00322
OG00434
Title
Denominators
Categories
Title
Measurements
OG0000.065(0.048 to 0.082)
OG0010.115(0.099 to 0.131)
OG0020.142(0.125 to 0.158)
OG0030.054(0.036 to 0.073)
OG004-0.011(-0.026 to 0.004)
Secondary
Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate
Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, 12 weeks and 24 weeks and 64 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00029
OG00130
OG00230
OG003
Title
Denominators
Categories
Week 12
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG003
Secondary
Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)
Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.
Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.
Participants who received at least one dose of study drug with baseline and at least one post-baseline femoral neck or total hip BMD value.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, 24 weeks and 52 weeks and 64 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00027
OG00129
OG00228
OG003
Title
Denominators
Categories
Femoral Neck BMD Week 24
ParticipantsOG00025
ParticipantsOG00128
ParticipantsOG00227
ParticipantsOG003
Secondary
Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)
Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).
Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.
Participants who received at least one dose of study drug with baseline and at least one post-baseline total radius of the wrist BMD value.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00024
OG00129
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.005(-0.011 to 0.001)
OG001-0.005(-0.010 to 0.001)
OG002-0.001(-0.007 to 0.005)
OG003
Secondary
Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)
Participants who received at least one dose of study drug with baseline and at least one post-baseline bone-specific alkaline phosphatase value.
Posted
Median
Inter-Quartile Range
units/liter
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00027
OG00129
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.000(-12.600 to 0.300)
OG001-2.000(-10.400 to 4.500)
OG0021.600(-4.400 to 9.800)
OG003
Secondary
Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)
Participants who received at least one dose of study drug with baseline and at least one post-baseline serum type I collagen fragment value.
Posted
Median
Inter-Quartile Range
nanograms/milliliter
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00026
OG00129
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.014(-0.116 to 0.079)
OG001-0.088(-0.191 to 0.030)
OG002-0.038(-0.199 to -0.009)
OG003
Secondary
Change From Baseline to 52 Week Endpoint in Osteocalcin
Participants who received at least one dose of study drug with baseline and at least one post-baseline osteocalcin value.
Posted
Median
Inter-Quartile Range
micrograms/liter
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00026
OG00129
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.087(-3.998 to 2.411)
OG001-0.764(-7.762 to 3.704)
OG0020.823(-3.704 to 5.116)
OG003
Secondary
Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)
Participants who received at least one dose of study drug with baseline and at least one post-baseline serum N-terminal extension propeptide of type I collagen value.
Posted
Median
Inter-Quartile Range
nanograms/milliliter
Baseline, 52 weeks
ID
Title
Description
OG000
180 mg LY2541546 Q4W + Placebo
LY2541546 + Placebo: 180 milligrams (mg) LY2541546 administered subcutaneously every 4 weeks (Q4W) for 52 weeks with Placebo administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.
OG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
OG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
OG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Units
Counts
Participants
OG00026
OG00129
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.250(-19.300 to 1.300)
OG001-4.200(-27.200 to 6.700)
OG002-1.100(-12.800 to 10.200)
4
31
30
31
EG001
180 mg LY2541546 Q2W
LY2541546: 180 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
3
30
28
30
EG002
270 mg LY2541546 Q2W
LY2541546: 270 mg administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
4
30
29
30
EG003
270 mg LY2541546 Q12W + Placebo
LY2541546 + Placebo: 270 mg LY2541546 administered subcutaneously every 12 weeks (Q12W) with Placebo administered subcutaneously every 2 weeks when LY2541546 is not administered for 52 weeks.
1
25
21
25
EG004
Placebo Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
2
37
34
37
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Retinal artery occlusion
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Mechanical ileus
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Pneumonia
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Pyelonephritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Cerebral infarction
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Spinal cord ischaemia
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0022 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Uterine prolapse
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected37 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
EG0000 events0 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0005 events3 affected31 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected37 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 16.0
Systematic Assessment
EG0006 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0032 events2 affected25 at risk
EG0040 events0 affected37 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected37 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected30 at risk
EG0023 events3 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Constipation
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Dental caries
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0015 events5 affected30 at risk
EG0023 events3 affected30 at risk
EG0031 events1 affected25 at risk
EG0044 events2 affected37 at risk
Gastritis
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Nausea
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0044 events2 affected37 at risk
Periodontal disease
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Fatigue
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 events2 affected31 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0044 events4 affected37 at risk
Injection site bruising
General disorders
MedDRA 16.0
Systematic Assessment
EG0004 events1 affected31 at risk
EG0019 events3 affected30 at risk
EG0027 events2 affected30 at risk
EG00311 events6 affected25 at risk
EG0043 events3 affected37 at risk
Injection site erythema
General disorders
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0015 events3 affected30 at risk
EG0023 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Injection site haemorrhage
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0043 events2 affected37 at risk
Injection site induration
General disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Injection site pain
General disorders
MedDRA 16.0
Systematic Assessment
EG0007 events4 affected31 at risk
EG0018 events5 affected30 at risk
EG0022 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Injection site pruritus
General disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0017 events5 affected30 at risk
EG0025 events4 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Injection site reaction
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0016 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Injection site swelling
General disorders
MedDRA 16.0
Systematic Assessment
EG00011 events6 affected31 at risk
EG0015 events3 affected30 at risk
EG00215 events5 affected30 at risk
EG0033 events2 affected25 at risk
EG0040 events0 affected37 at risk
Oedema peripheral
General disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Hepatic cyst
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Asymptomatic bacteriuria
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Bronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0032 events1 affected25 at risk
EG0042 events2 affected37 at risk
Cystitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG0032 events2 affected25 at risk
EG0043 events2 affected37 at risk
Gastroenteritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Gastrointestinal viral infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Herpes simplex
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected37 at risk
Herpes zoster
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Influenza
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0031 events1 affected25 at risk
EG0042 events2 affected37 at risk
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG00020 events16 affected31 at risk
EG00111 events8 affected30 at risk
EG00219 events11 affected30 at risk
EG0038 events7 affected25 at risk
EG00416 events12 affected37 at risk
Oral herpes
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Periodontitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0043 events3 affected37 at risk
Pharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0014 events3 affected30 at risk
EG0023 events3 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Pneumonia
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Pulpitis dental
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0043 events3 affected37 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Rhinitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0024 events4 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Sinusitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected30 at risk
EG0024 events4 affected30 at risk
EG0032 events2 affected25 at risk
EG0041 events1 affected37 at risk
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0032 events2 affected25 at risk
EG0041 events1 affected37 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0013 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0046 events5 affected37 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Blood 1,25-dihydroxycholecalciferol increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected31 at risk
EG0015 events4 affected30 at risk
EG0024 events4 affected30 at risk
EG0032 events2 affected25 at risk
EG0045 events5 affected37 at risk
Hepatic enzyme increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Urine calcium decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Urine phosphorus decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events3 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0042 events2 affected37 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0003 events2 affected31 at risk
EG0015 events3 affected30 at risk
EG0022 events2 affected30 at risk
EG0032 events2 affected25 at risk
EG0045 events5 affected37 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0006 events6 affected31 at risk
EG0014 events3 affected30 at risk
EG0022 events2 affected30 at risk
EG0032 events2 affected25 at risk
EG0044 events4 affected37 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0042 events2 affected37 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected25 at risk
EG0040 events0 affected37 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0013 events3 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0040 events0 affected37 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0004 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0014 events4 affected30 at risk
EG0021 events1 affected30 at risk
EG0031 events1 affected25 at risk
EG0043 events2 affected37 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected30 at risk
EG0031 events1 affected25 at risk
EG0041 events1 affected37 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected25 at risk
EG0041 events1 affected37 at risk
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)