Extension Study to Evaluate the Long Term Safety and Effi... | NCT00523341 | Trialant
NCT00523341
Sponsor
Amgen
Status
Completed
Last Update Posted
Nov 7, 2022Actual
Enrollment
4,550Actual
Phase
Phase 3
Conditions
Osteopenia
Osteoporosis
Interventions
Denosumab
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
NCT00523341
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20060289
Secondary IDs
Not provided
Brief Title
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
Official Title
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Nov 2022
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 7, 2007Actual
Primary Completion Date
Jul 19, 2015Actual
Completion Date
Jul 19, 2015Actual
First Submitted Date
Aug 30, 2007
First Submission Date that Met QC Criteria
Aug 30, 2007
First Posted Date
Aug 31, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 1, 2016
Results First Submitted that Met QC Criteria
Jun 1, 2016
Results First Posted Date
Jul 12, 2016Estimated
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
Nov 4, 2022
Last Update Posted Date
Nov 7, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 objective was to describe the safety and tolerability of up to 10 years or 7 years denosumab administration as measured by adverse event monitoring, immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.
Detailed Description
Not provided
Conditions Module
Conditions
Osteopenia
Osteoporosis
Keywords
postmenopausal osteoporosis
low bone density
fractures
low bone mass
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
4,550Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Denosumab
Experimental
Participants received a 60 mg subcutaneous injection of denosumab every 6 months for seven years.
Biological: Denosumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Denosumab
Biological
Administered by subcutaneous injection once every 6 months.
Denosumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs)
A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.
84 months
Number of Participants With Laboratory Toxicities of Grade ≥ 3
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.
84 months
Number of Participants With Antibodies to Denosumab
Every 12 months through Month 84
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline (of extension study) and months 12, 24, 36, 60 and 84
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will be eligible to participate if they meet the inclusion and exclusion criteria given below.
Inclusion Criteria
Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months
Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit
Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.
Exclusion Criteria
Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc. is permitted)
Missed 2 or more investigational product doses during the 20030216 study
Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Developed sensitivity to mammalian cell derived drug products during the 20030216 study
Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium, or tibolone
For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
Cummings SR, Ferrari S, Eastell R, Gilchrist N, Jensen JB, McClung M, Roux C, Torring O, Valter I, Wang AT, Brown JP. Vertebral Fractures After Discontinuation of Denosumab: A Post Hoc Analysis of the Randomized Placebo-Controlled FREEDOM Trial and Its Extension. J Bone Miner Res. 2018 Feb;33(2):190-198. doi: 10.1002/jbmr.3337. Epub 2017 Nov 22.
All participants received open-label denosumab during this study. Results are reported by the Study 20030216 randomized treatment groups (placebo versus denosumab).
Recruitment Details
This was an extension study open to participants who had completed core study 20030216 (NCT00089791). The study was conducted at 178 centers in North America, South America, Europe, Australia, and New Zealand. Participants were enrolled from 7 August 2007 to 20 June 2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
FG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0002207 subjects
FG0012343 subjects
Received Treatment
FG0002206 subjects
FG0012343 subjects
COMPLETED
FG0001283 subjects
FG0011343 subjects
NOT COMPLETED
FG000924 subjects
FG0011000 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG000399 subjects
FG001427 subjects
Other
FG000181 subjects
FG001
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
BG001
Denosumab / Denosumab
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
Number of Participants With Adverse Events (AEs)
A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.
All participants who received at least one dose of denosumab.
Posted
Number
participants
84 months
ID
Adverse Events Module
Frequency Threshold
5
Time Frame
84 months
Description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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
Placebo/ Denosumab 60 mg Q6M
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
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
Study Director
Amgen Inc.
866-572-6436
Jul 10, 2026
Removed Countries
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Malta
Mexico
New Zealand
Norway
Poland
Romania
Serbia
Serbia and Montenegro
Slovakia
Spain
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
D001851
Bone Diseases, Metabolic
D010024
Osteoporosis
D015663
Osteoporosis, Postmenopausal
D050723
Fractures, Bone
Ancestor Terms
ID
Term
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000069448
Denosumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
Browse Leaves
Not provided
Browse Branches
Not provided
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
AMG 162
Prolia
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline (of extension study) and months 12, 24, 36, 60 and 84
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit
Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline (of extension study) and months 12, 24, 36, 60 and 84
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit
1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Baseline (of extension study) and months 12, 24, 36, 60 and 84
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit
Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit
Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit
1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84
Number of Participants With New Vertebral Fractures
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.
84 months
Number of Participants With Non-Vertebral Fractures
Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
84 months
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
Percent Change From Study 20030216 Baseline in CTX-1 by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
Percent Change From Study 20030216 Baseline in P1NP by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10
Baseline (of extension study) and day 10
Serum Denosumab Concentration
Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.
Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)
Bone Histomorphometry: Cancellous Bone Volume
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.
Month 24 and month 84
Bone Histomorphometry: Trabecular Number
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.
Month 24 and month 84
Bone Histomorphometry: Trabecular Separation
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.
Month 24 and month 84
Bone Histomorphometry: Trabecular Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.
Month 24 and month 84
Bone Histomorphometry: Cortical Width
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.
Month 24 and month 84
Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.
Month 24 and month 84
Bone Histomorphometry: Surface Density
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.
Month 24 and month 84
Bone Histomorphometry: Osteoblast - Osteoid Interface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.
Month 24 and month 84
Bone Histomorphometry: Osteoid Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.
Month 24 and month 84
Bone Histomorphometry: Osteoid Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).
Month 24 and month 84
Bone Histomorphometry: Wall Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.
Month 24 and month 84
Bone Histomorphometry: Eroded Surface/Bone Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts.
Month 24 and month 84
Bone Histomorphometry: Osteoclast Number - Length Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone.
Month 24 and month 84
Bone Histomorphometry: Osteoclast Number - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area.
Month 24 and month 84
Bone Histomorphometry: Osteoclast Number by TRAP - Length Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per mm of bone.
Month 24 and month 84
Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.
Da
Month 24 and month 84
Bone Histomorphometry: Single-label Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface.
Month 24 and month 84
Bone Histomorphometry: Double-label Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface.
Month 24 and month 84
Bone Histomorphometry: Mineralizing Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.
Month 24 and month 84
Bone Histomorphometry: Mineral Apposition Rate
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.
Month 24 and month 84
Bone Histomorphometry: Adjusted Apposition Rate
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).
Month 24 and month 84
Bone Histomorphometry: Bone Formation Rate - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface).
Month 24 and month 84
Bone Histomorphometry: Bone Formation Rate - Volume Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).
Month 24 and month 84
Bone Histomorphometry: Formation Period
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate.
Month 24 and month 84
Bone Histomorphometry: Activation Frequency
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width.
Month 24 and month 84
Bone Histomorphometry: Osteoid Volume
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).
Month 24 and month 84
Bone Histomorphometry: Mineralization Lag Time
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.
Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate.
Month 24 and month 84
Bone Histology at Month 24
Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.
Month 24
Bone Histology at Month 84
Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.
Month 84
Background
Dempster DW, Brown JP, Fahrleitner-Pammer A, Kendler D, Rizzo S, Valter I, Wagman RB, Yin X, Yue SV, Boivin G. Effects of Long-Term Denosumab on Bone Histomorphometry and Mineralization in Women With Postmenopausal Osteoporosis. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2498-2509. doi: 10.1210/jc.2017-02669.
Bone HG, Wagman RB, Brandi ML, Brown JP, Chapurlat R, Cummings SR, Czerwinski E, Fahrleitner-Pammer A, Kendler DL, Lippuner K, Reginster JY, Roux C, Malouf J, Bradley MN, Daizadeh NS, Wang A, Dakin P, Pannacciulli N, Dempster DW, Papapoulos S. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523. doi: 10.1016/S2213-8587(17)30138-9. Epub 2017 May 22.
Ferrari S, Eastell R, Napoli N, Schwartz A, Hofbauer LC, Chines A, Wang A, Pannacciulli N, Cummings SR. Denosumab in postmenopausal women with osteoporosis and diabetes: Subgroup analysis of FREEDOM and FREEDOM extension. Bone. 2020 May;134:115268. doi: 10.1016/j.bone.2020.115268. Epub 2020 Feb 10.
Ferrari S, Lewiecki EM, Butler PW, Kendler DL, Napoli N, Huang S, Crittenden DB, Pannacciulli N, Siris E, Binkley N. Favorable skeletal benefit/risk of long-term denosumab therapy: A virtual-twin analysis of fractures prevented relative to skeletal safety events observed. Bone. 2020 May;134:115287. doi: 10.1016/j.bone.2020.115287. Epub 2020 Feb 21.
Kendler DL, Chines A, Brandi ML, Papapoulos S, Lewiecki EM, Reginster JY, Munoz Torres M, Wang A, Bone HG. The risk of subsequent osteoporotic fractures is decreased in subjects experiencing fracture while on denosumab: results from the FREEDOM and FREEDOM Extension studies. Osteoporos Int. 2019 Jan;30(1):71-78. doi: 10.1007/s00198-018-4687-2. Epub 2018 Sep 22.
Watts NB, Brown JP, Papapoulos S, Lewiecki EM, Kendler DL, Dakin P, Wagman RB, Wang A, Daizadeh NS, Smith S, Bone HG. Safety Observations With 3 Years of Denosumab Exposure: Comparison Between Subjects Who Received Denosumab During the Randomized FREEDOM Trial and Subjects Who Crossed Over to Denosumab During the FREEDOM Extension. J Bone Miner Res. 2017 Jul;32(7):1481-1485. doi: 10.1002/jbmr.3119. Epub 2017 Apr 3.
Watts NB, Grbic JT, Binkley N, Papapoulos S, Butler PW, Yin X, Tierney A, Wagman RB, McClung M. Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2443-2452. doi: 10.1210/jc.2018-01965.
Adachi JD, Bone HG, Daizadeh NS, Dakin P, Papapoulos S, Hadji P, Recknor C, Bolognese MA, Wang A, Lin CJF, Wagman RB, Ferrari S. Influence of subject discontinuation on long-term nonvertebral fracture rate in the denosumab FREEDOM Extension study. BMC Musculoskelet Disord. 2017 Apr 27;18(1):174. doi: 10.1186/s12891-017-1520-6.
Bilezikian JP, Lin CJF, Brown JP, Wang AT, Yin X, Ebeling PR, Fahrleitner-Pammer A, Franek E, Gilchrist N, Miller PD, Simon JA, Valter I, Zerbini CAF, Libanati C, Chines A. Long-term denosumab treatment restores cortical bone loss and reduces fracture risk at the forearm and humerus: analyses from the FREEDOM Extension cross-over group. Osteoporos Int. 2019 Sep;30(9):1855-1864. doi: 10.1007/s00198-019-05020-8. Epub 2019 Jun 14.
Ferrari S, Butler PW, Kendler DL, Miller PD, Roux C, Wang AT, Huang S, Wagman RB, Lewiecki EM. Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3450-3461. doi: 10.1210/jc.2019-00271.
Ferrari S, Libanati C, Lin CJF, Brown JP, Cosman F, Czerwinski E, de Gregomicronrio LH, Malouf-Sierra J, Reginster JY, Wang A, Wagman RB, Lewiecki EM. Relationship Between Bone Mineral Density T-Score and Nonvertebral Fracture Risk Over 10 Years of Denosumab Treatment. J Bone Miner Res. 2019 Jun;34(6):1033-1040. doi: 10.1002/jbmr.3722. Epub 2019 May 29.
Broadwell A, Chines A, Ebeling PR, Franek E, Huang S, Smith S, Kendler D, Messina O, Miller PD. Denosumab Safety and Efficacy Among Participants in the FREEDOM Extension Study With Mild to Moderate Chronic Kidney Disease. J Clin Endocrinol Metab. 2021 Jan 23;106(2):397-409. doi: 10.1210/clinem/dgaa851.
Cosman F, Huang S, McDermott M, Cummings SR. Multiple Vertebral Fractures After Denosumab Discontinuation: FREEDOM and FREEDOM Extension Trials Additional Post Hoc Analyses. J Bone Miner Res. 2022 Nov;37(11):2112-2120. doi: 10.1002/jbmr.4705. Epub 2022 Oct 12.
Bone HG, Chapurlat R, Brandi ML, Brown JP, Czerwinski E, Krieg MA, Mellstrom D, Radominski SC, Reginster JY, Resch H, Ivorra JA, Roux C, Vittinghoff E, Daizadeh NS, Wang A, Bradley MN, Franchimont N, Geller ML, Wagman RB, Cummings SR, Papapoulos S. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab. 2013 Nov;98(11):4483-92. doi: 10.1210/jc.2013-1597. Epub 2013 Aug 26.
Papapoulos S, Chapurlat R, Libanati C, Brandi ML, Brown JP, Czerwinski E, Krieg MA, Man Z, Mellstrom D, Radominski SC, Reginster JY, Resch H, Roman Ivorra JA, Roux C, Vittinghoff E, Austin M, Daizadeh N, Bradley MN, Grauer A, Cummings SR, Bone HG. Five years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extension. J Bone Miner Res. 2012 Mar;27(3):694-701. doi: 10.1002/jbmr.1479.
198 subjects
Adverse Event
FG000122 subjects
FG001155 subjects
Death
FG000101 subjects
FG001110 subjects
Lost to Follow-up
FG00073 subjects
FG00161 subjects
Non-compliance
FG00020 subjects
FG00113 subjects
Physician Decision
FG00014 subjects
FG00113 subjects
Requirement for Alternative Therapy
FG0004 subjects
FG00114 subjects
Protocol Deviation
FG0006 subjects
FG0015 subjects
Ineligibility Determined
FG0003 subjects
FG0014 subjects
Disease Progression
FG0001 subjects
FG0010 subjects
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
BG002
Total
Total of all reporting groups
2207
BG0012343
BG0024550
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00074.8± 5.1
BG00174.9± 5.0
BG00274.8± 5.0
Age, Customized
Number
participants
Title
Denominators
Categories
60 - 64 years
Title
Measurements
BG00058
BG00149
BG002107
65 - 69 years
Title
Measurements
BG000326
BG001320
BG002646
70 - 74 years
Title
Measurements
BG000672
BG001716
BG0021388
≥ 75 years
Title
Measurements
BG0001151
BG0011258
BG0022409
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002207
BG0012343
BG0024550
Male
BG0000
BG0010
BG0020
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG0002063
BG0012169
BG0024232
Black
Title
Measurements
BG00016
BG00119
BG00235
Hispanic or Latino
Title
Measurements
BG000121
BG001145
BG002266
Asian
Title
Measurements
BG0002
BG0013
BG0025
Japanese
Title
Measurements
BG0003
BG0015
BG0028
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0001
BG0010
BG0021
Other
Title
Measurements
BG0001
BG0012
BG0023
Bone Mineral Density T-score
The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old.
Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman.
Mean
Standard Deviation
T-score
Title
Denominators
Categories
Lumbar spine
Title
Measurements
BG000-2.81± 0.75
BG001-2.14± 0.80
BG002-2.47± 0.84
Total hip
Title
Measurements
BG000-1.93± 0.80
BG001-1.50± 0.79
BG002-1.71± 0.83
Femoral neck
Title
Measurements
BG000-2.17± 0.72
BG001-1.83± 0.75
BG002-1.99± 0.75
Bone Mineral Density T-score at Study 20030216 Baseline
Mean
Standard Deviation
T-score
Title
Denominators
Categories
Lumbar spine
Title
Measurements
BG000-2.84± 0.68
BG001-2.83± 0.67
BG002-2.83± 0.68
Total hip
Title
Measurements
BG000-1.85± 0.79
BG001-1.85± 0.79
BG002-1.85± 0.79
Femoral neck
Title
Measurements
BG000-2.11± 0.71
BG001-2.11± 0.71
BG002-2.11± 0.71
Any Historical Fracture at Age ≥ 55 Years
Number
participants
Title
Denominators
Categories
Title
Measurements
BG0001089
BG0011133
BG0022222
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002206
OG0012343
Title
Denominators
Categories
Any adverse event (AE)
Title
Measurements
OG0002070
OG0012173
Serious adverse event
Title
Measurements
OG000945
OG0011014
Fatal adverse event
Title
Measurements
OG000101
OG001108
AE leading to study discontinuation
Title
Measurements
OG000145
OG001173
AE leading to discontinuation of denosumab
Title
Measurements
OG000184
OG001216
Treatment-related adverse events (TRAE)
Title
Measurements
OG000185
OG001188
Serious treatment-related adverse events
Title
Measurements
OG00026
OG00128
Fatal treatment-related adverse events
Title
Measurements
OG0001
OG0010
TRAE leading to study discontinuation
Title
Measurements
OG00016
OG0019
TRAE leading to discontinuation of denosumab
Title
Measurements
OG00030
OG00125
Positively adjudicated osteonecrosis of the jaw
Title
Measurements
OG0006
OG0017
Positively adjudicated atypical femoral fracture
Title
Measurements
OG0001
OG0011
Hypocalcaemia
Title
Measurements
OG00010
OG0016
AEs potentially related to hypersensitivity
Title
Measurements
OG000260
OG001280
Serious infections
Title
Measurements
OG000161
OG001185
Serious bacterial cellulitis
Title
Measurements
OG0007
OG00112
Malignancy
Title
Measurements
OG000227
OG001237
Cardiac disorders
Title
Measurements
OG000449
OG001492
Vascular disorders
Title
Measurements
OG000693
OG001732
Fracture healing complications
Title
Measurements
OG0000
OG0011
Eczema
Title
Measurements
OG00099
OG001115
Acute pancreatitis
Title
Measurements
OG0004
OG0018
Musculoskeletal pain
Title
Measurements
OG0001125
OG0011206
Primary
Number of Participants With Laboratory Toxicities of Grade ≥ 3
Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.
All participants who received at least 1 dose of denosumab
Posted
Number
participants
84 months
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002206
OG0012343
Title
Denominators
Categories
Low sodium - Grade 3
Title
Measurements
OG00028
OG00125
Low sodium - Grade 4
Title
Measurements
OG000
Primary
Number of Participants With Antibodies to Denosumab
All participants who received at least 1 dose of denosumab
Posted
Number
participants
Every 12 months through Month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002206
OG0012343
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
Secondary
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (of extension study) and months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2040, 2168)
Title
Measurements
OG0005.2(5.0 to 5.3)
OG0012.0(1.8 to 2.2)
Month 24 (n = 1935, 2061)
Title
Measurements
OG000
Secondary
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (of extension study) and months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2029, 2160)
Title
Measurements
OG0003.0(2.8 to 3.1)
OG0010.8(0.7 to 0.9)
Month 24 (n = 1918, 2045)
Title
Measurements
OG000
Secondary
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit
Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (of extension study) and months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2029, 2160)
Title
Measurements
OG0002.1(1.9 to 2.3)
OG0010.8(0.7 to 1.0)
Month 24 (n = 1918, 2045)
Title
Measurements
OG000
Secondary
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit
1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (of extension study) and months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000449
OG001467
Title
Denominators
Categories
Month 12 (n = 114, 134)
Title
Measurements
OG0000.3(-0.2 to 0.9)
OG0010.6(0.1 to 1.2)
Month 24 (n = 108, 127)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit
Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2030, 2148)
Title
Measurements
OG0005.9(5.6 to 6.1)
OG00111.9(11.7 to 12.2)
Month 24 (n = 1924, 2041)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit
Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2006, 2132)
Title
Measurements
OG0001.7(1.6 to 1.9)
OG0016.4(6.3 to 6.6)
Month 24 (n = 1895, 2017)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit
Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002089
OG0012210
Title
Denominators
Categories
Month 12 (n = 2006, 2132)
Title
Measurements
OG0001.4(1.2 to 1.7)
OG0015.8(5.6 to 6.0)
Month 24 (n = 1895, 2017)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit
1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.
Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000449
OG001467
Title
Denominators
Categories
Month 12 (n = 113, 133)
Title
Measurements
OG000-1.0(-1.7 to -0.3)
OG0012.6(1.9 to 3.2)
Month 24 (n = 107, 127)
Title
Measurements
OG000
Secondary
Number of Participants With New Vertebral Fractures
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.
All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.
Posted
Number
participants
84 months
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0001991
OG0012116
Title
Denominators
Categories
Title
Measurements
OG000145
OG001149
Secondary
Number of Participants With Non-Vertebral Fractures
Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
All enrolled participants
Posted
Number
participants
84 months
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002207
OG0012343
Title
Denominators
Categories
Title
Measurements
OG000219
OG001172
Secondary
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.
Posted
Median
Inter-Quartile Range
percent change
Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000318
OG001342
Title
Denominators
Categories
Day 10 (n = 26, 47)
Title
Measurements
OG000-90(-93 to -85)
OG001-72(-86 to -47)
Month 6 (n = 30, 56)
Title
Measurements
OG000
Secondary
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.
Posted
Median
Inter-Quartile Range
percent change
Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000318
OG001342
Title
Denominators
Categories
Day 10 (n = 30, 51)
Title
Measurements
OG0006(-5 to 30)
OG00114(-1 to 25)
Month 6 (n = 30, 53)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in CTX-1 by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.
Posted
Median
Inter-Quartile Range
percent change
Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000318
OG001342
Title
Denominators
Categories
Day 10 (n = 26, 56)
Title
Measurements
OG000-90(-91 to -78)
OG001-91(-93 to -86)
Month 6 (n = 32, 72)
Title
Measurements
OG000
Secondary
Percent Change From Study 20030216 Baseline in P1NP by Visit
Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.
Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.
Posted
Median
Inter-Quartile Range
percent change
Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG000318
OG001342
Title
Denominators
Categories
Day 10 (n = 30, 51)
Title
Measurements
OG0009(-14 to 34)
OG001-59(-74 to -22)
Month 6 (n = 32, 57)
Title
Measurements
OG000
Secondary
Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10
Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.
Posted
Median
Inter-Quartile Range
percent change
Baseline (of extension study) and day 10
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0002027
OG0012154
Title
Denominators
Categories
Title
Measurements
OG000-3.1(-6.1 to 0.0)
OG001-2.0(-5.1 to 1.1)
Secondary
Serum Denosumab Concentration
Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.
Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.
Posted
Mean
Standard Deviation
ng/mL
Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00097
OG001113
Title
Denominators
Categories
Baseline (n = 97, 113)
Title
Measurements
OG0000± 0
OG001113± 107
Day 10 (n = 92, 106)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Cancellous Bone Volume
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.
Posted
Mean
Standard Deviation
percentage of total bone tissue volume
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG00015.253± 6.065
OG00114.640± 6.979
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Trabecular Number
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular number data.
Posted
Mean
Standard Deviation
1/mm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0001.005± 0.242
OG0010.904± 0.243
Month 24 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Trabecular Separation
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular separation data.
Posted
Mean
Standard Deviation
μm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG000919.693± 358.238
OG0011033.416± 352.259
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Trabecular Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular thickness data.
Posted
Mean
Standard Deviation
μm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG000153.878± 51.859
OG001156.335± 48.567
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Cortical Width
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cortical width data.
Posted
Mean
Standard Deviation
μm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00145
Title
Denominators
Categories
Month 24 (n = 13, 28)
Title
Measurements
OG000622.22± 246.70
OG001707.69± 237.97
Month 84 (n = 0, 21)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.
Posted
Mean
Standard Deviation
percentage of total bone tissue volume
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG00016.678± 7.270
OG00115.606± 6.986
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Surface Density
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available surface density data.
Posted
Mean
Standard Deviation
mm²/mm³
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0002.009± 0.486
OG0011.807± 0.486
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoblast - Osteoid Interface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoblast - osteoid interface data.
Posted
Mean
Standard Deviation
percentage of osteoid surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG00022.124± 34.879
OG00117.813± 28.381
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoid Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid surface data.
Posted
Mean
Standard Deviation
percentage of total bone surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0000.915± 1.382
OG0010.982± 2.489
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoid Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid thickness data.
Posted
Mean
Standard Deviation
μm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0005.139± 3.261
OG0014.548± 4.973
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Wall Thickness
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available wall thickness data.
Posted
Mean
Standard Deviation
μm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG00043.11± 6.08
OG00149.74± 10.51
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Eroded Surface/Bone Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available eroded surface/bone surface data.
Posted
Mean
Standard Deviation
percentage of bone surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0000.414± 0.701
OG0010.328± 0.613
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoclast Number - Length Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.
Posted
Mean
Standard Deviation
1/mm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0000.086± 0.119
OG0010.107± 0.198
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoclast Number - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.
Posted
Mean
Standard Deviation
1/100 mm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0008.6± 11.9
OG00110.7± 19.8
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoclast Number by TRAP - Length Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per mm of bone.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.
Posted
Mean
Standard Deviation
1/mm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0000.096± 0.134
OG0010.110± 0.185
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.
Da
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.
Posted
Mean
Standard Deviation
1/100 mm
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0009.6± 13.4
OG00111.0± 18.5
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Single-label Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available single-label surface data.
Posted
Mean
Standard Deviation
percentage of bone surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.304± 0.302
OG0010.643± 0.661
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Double-label Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available double-label surface data.
Posted
Mean
Standard Deviation
percentage of bone surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.258± 0.207
OG0010.356± 0.295
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Mineralizing Surface
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralizing surface data.
Posted
Mean
Standard Deviation
percentage of bone surface
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.406± 0.323
OG0010.681± 0.453
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Mineral Apposition Rate
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineral apposition rate data.
Posted
Mean
Standard Deviation
μm/day
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.616± 0.219
OG0010.722± 0.573
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Adjusted Apposition Rate
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available adjusted apposition rate data.
Posted
Mean
Standard Deviation
μm/day
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00119
Title
Denominators
Categories
Month 24 (n = 5, 9)
Title
Measurements
OG0000.394± 0.471
OG0010.517± 0.537
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Bone Formation Rate - Surface Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface).
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.
Posted
Mean
Standard Deviation
μm³/μm²/year
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.898± 0.706
OG0012.153± 2.468
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Bone Formation Rate - Volume Based
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.
Posted
Mean
Standard Deviation
percent of bone volume per year
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0001.454± 1.265
OG0013.162± 3.773
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Formation Period
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available formation period data.
Posted
Mean
Standard Deviation
days
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG000593.5± 996.8
OG001287.3± 391.5
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Activation Frequency
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available activation frequency data.
Posted
Mean
Standard Deviation
/year
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG0000.022± 0.019
OG0010.045± 0.049
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Osteoid Volume
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.
Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid volume data.
Posted
Mean
Standard Deviation
percentage of total bone tissue
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00141
Title
Denominators
Categories
Month 24 (n = 13, 25)
Title
Measurements
OG0000.108± 0.193
OG0010.146± 0.382
Month 84 (n = 0, 19)
Title
Measurements
OG000
Secondary
Bone Histomorphometry: Mineralization Lag Time
Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.
Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralization lag time data.
Posted
Mean
Standard Deviation
days
Month 24 and month 84
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0005
OG00120
Title
Denominators
Categories
Month 24 (n = 5, 10)
Title
Measurements
OG00084.9± 136.8
OG00154.3± 76.1
Month 84 (n = 0, 10)
Title
Measurements
OG000
Secondary
Bone Histology at Month 24
Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 24.
Posted
Number
biopsies
Month 24
biopsies
biopsies
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG00013
OG00128
biopsies
OG00013
OG00128
Title
Denominators
Categories
Normal lamellar bone
Title
Measurements
OG00013
OG00128
Normal mineralization
Title
Measurements
OG000
Secondary
Bone Histology at Month 84
Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.
Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 84.
Posted
Number
biopsies
Month 84
biopsies
biopsies
ID
Title
Description
OG000
Placebo / Denosumab
Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
OG001
Denosumab / Denosumab
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Units
Counts
Participants
OG0000
OG00122
biopsies
OG0000
OG00122
Title
Denominators
Categories
Normal lamellar bone
Title
Measurements
OG00122
Normal mineralization
Title
Measurements
OG00122
Osteoid
945
2,206
1,809
2,206
EG001
Denosumab/ Denosumab 60 mg Q6M
Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
1,014
2,343
1,920
2,343
EG00011 affected2,206 at risk
EG00111 affected2,343 at risk
Bone marrow oedema
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Haemorrhagic disorder
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pancytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Polycythaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Splenomegaly
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG00118 affected2,343 at risk
Adams-Stokes syndrome
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Angina pectoris
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG00017 affected2,206 at risk
EG00119 affected2,343 at risk
Angina unstable
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG00112 affected2,343 at risk
Aortic valve disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Aortic valve incompetence
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Aortic valve stenosis
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0013 affected2,343 at risk
Arrhythmia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0014 affected2,343 at risk
Arrhythmia supraventricular
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG00050 affected2,206 at risk
EG00140 affected2,343 at risk
Atrial flutter
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0014 affected2,343 at risk
Atrioventricular block
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Atrioventricular block complete
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0014 affected2,343 at risk
Atrioventricular block second degree
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Bradycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Bundle branch block left
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cardiac arrest
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Cardiac disorder
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cardiac failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG00015 affected2,206 at risk
EG00121 affected2,343 at risk
Cardiac failure acute
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Cardiac failure chronic
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected2,206 at risk
EG0019 affected2,343 at risk
Cardiac fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cardiac valve disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Cardiac valve sclerosis
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cardio-respiratory arrest
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Cardiogenic shock
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Cardiomyopathy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cardiopulmonary failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Cardiovascular insufficiency
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Chronic right ventricular failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Coronary artery disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG00117 affected2,343 at risk
Coronary artery insufficiency
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Coronary artery occlusion
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Coronary artery stenosis
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0016 affected2,343 at risk
Extrasystoles
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Heart valve calcification
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Heart valve incompetence
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypertensive heart disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Left atrial dilatation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Left ventricular failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Mitral valve disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Mitral valve disease mixed
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mitral valve incompetence
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG00021 affected2,206 at risk
EG00124 affected2,343 at risk
Myocardial ischaemia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG00113 affected2,343 at risk
Palpitations
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Pericardial effusion
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Pericardial haemorrhage
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pericarditis
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Right ventricular failure
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Sinoatrial block
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Sinus arrest
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Sinus node dysfunction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG00110 affected2,343 at risk
Supraventricular extrasystoles
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Supraventricular tachyarrhythmia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Tachyarrhythmia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tachycardia induced cardiomyopathy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tricuspid valve disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Ventricular arrhythmia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Ventricular fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Ventricular tachycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Cancer gene carrier
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Congenital ureteric anomaly
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Corneal dystrophy
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Muscular dystrophy
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Deafness unilateral
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypoacusis
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Meniere's disease
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Otosclerosis
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected2,206 at risk
EG0018 affected2,343 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Vestibular disorder
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Adrenal mass
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Basedow's disease
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Goitre
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0015 affected2,343 at risk
Hyperthyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Thyroiditis
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Toxic nodular goitre
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Blepharochalasis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Blindness
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Blindness unilateral
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cataract
Eye disorders
MedDRA 18.0
Systematic Assessment
EG00017 affected2,206 at risk
EG00115 affected2,343 at risk
Cataract diabetic
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Detachment of macular retinal pigment epithelium
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Diplopia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Ectropion
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Eye haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Glaucoma
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Iridocyclitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Keratopathy
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Macular fibrosis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Maculopathy
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Open angle glaucoma
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Retinal detachment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Retinal haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Retinal tear
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Retinal vascular thrombosis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ulcerative keratitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Visual impairment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Vitreous haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Abdominal adhesions
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Abdominal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Abdominal hernia obstructive
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected2,206 at risk
EG0018 affected2,343 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Abdominal rigidity
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Acquired oesophageal web
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Anal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Anal prolapse
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Anal sphincter atony
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Chronic gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Coeliac disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0012 affected2,343 at risk
Colitis ischaemic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Colitis microscopic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Colitis ulcerative
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG0016 affected2,343 at risk
Crohn's disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Diaphragmatic hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG0013 affected2,343 at risk
Diverticular perforation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Diverticulum
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0016 affected2,343 at risk
Diverticulum oesophageal
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Duodenal stenosis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Duodenal ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Duodenitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Enteritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Enterocolitis haemorrhagic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Epigastric discomfort
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Faecal incontinence
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Faeces discoloured
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Femoral hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastric ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0013 affected2,343 at risk
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0019 affected2,343 at risk
Gastritis erosive
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Gastroduodenal ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0011 affected2,343 at risk
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastrointestinal mucosal disorder
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Gastrointestinal stenosis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0012 affected2,343 at risk
Haematemesis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Hernial eventration
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hiatus hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0014 affected2,343 at risk
Ileus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0013 affected2,343 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected2,206 at risk
EG0017 affected2,343 at risk
Intestinal angina
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intestinal fistula
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0011 affected2,343 at risk
Intestinal perforation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intestinal strangulation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Large intestinal stenosis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Large intestine polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Malabsorption
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mechanical ileus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Melaena
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Mesenteric artery embolism
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Oesophageal polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pancreatic cyst
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Pancreatic necrosis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0014 affected2,343 at risk
Pancreatitis acute
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0014 affected2,343 at risk
Pancreatitis chronic
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Peptic ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Periodontal disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Peritoneal perforation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pharyngo-oesophageal diverticulum
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Rectal polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Rectal prolapse
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0014 affected2,343 at risk
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Subileus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Tongue oedema
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Toothache
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Umbilical hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Volvulus
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Volvulus of small bowel
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Adverse drug reaction
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0014 affected2,343 at risk
Chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG0018 affected2,343 at risk
Chronic fatigue syndrome
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Death
General disorders
MedDRA 18.0
Systematic Assessment
EG00016 affected2,206 at risk
EG00113 affected2,343 at risk
Device dislocation
General disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0015 affected2,343 at risk
Device failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Device malfunction
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Face oedema
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Foreign body reaction
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gait disturbance
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
General physical health deterioration
General disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Hernia
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Incarcerated hernia
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Inflammation
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Ischaemic ulcer
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Malaise
General disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Medical device complication
General disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Multi-organ failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0014 affected2,343 at risk
Nodule
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0015 affected2,343 at risk
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Peripheral swelling
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Polyp
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Sudden cardiac death
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Sudden death
General disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Ulcer haemorrhage
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bile duct obstruction
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Bile duct stenosis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Bile duct stone
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0014 affected2,343 at risk
Biliary cirrhosis primary
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Biliary colic
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0015 affected2,343 at risk
Cholangitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0014 affected2,343 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG00022 affected2,206 at risk
EG00130 affected2,343 at risk
Gallbladder necrosis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gallbladder oedema
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gallbladder polyp
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatic cyst
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Jaundice
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Liver disorder
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Anaphylactic reaction
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Autoimmune disorder
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Drug hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hypersensitivity
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Sarcoidosis
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Abdominal abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Abdominal sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Abscess limb
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Abscess neck
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Appendiceal abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Appendicitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Appendicitis perforated
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Arthritis bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Arthritis infective
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Atypical pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Bacterial infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bacterial pyelonephritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG0017 affected2,343 at risk
Bronchitis fungal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bronchopneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0016 affected2,343 at risk
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0012 affected2,343 at risk
Cholecystitis infective
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Chronic sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Chronic tonsillitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Clostridium difficile infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cystitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0015 affected2,343 at risk
Dengue fever
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Device related infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Diverticulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00011 affected2,206 at risk
EG00110 affected2,343 at risk
Ear infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Endocarditis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Enterocolitis bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Erysipelas
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0019 affected2,343 at risk
Gangrene
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG0019 affected2,343 at risk
Gastroenteritis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Gastrointestinal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
H1N1 influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Haemophilus infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Helicobacter gastritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Hepatic cyst infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatitis C
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Infected skin ulcer
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Klebsiella bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Klebsiella infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Laryngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Listeriosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Liver abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Lobar pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0014 affected2,343 at risk
Localised infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0016 affected2,343 at risk
Lung infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Lymph node tuberculosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Meningitis aseptic
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Meningitis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mycobacterium avium complex infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Necrotising fasciitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Neutropenic sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Onychomycosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Osteomyelitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Otitis media
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Parotitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Peritonitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00044 affected2,206 at risk
EG00148 affected2,343 at risk
Pneumonia bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0014 affected2,343 at risk
Pneumonia haemophilus
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumonia influenzal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pneumonia pneumococcal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0012 affected2,343 at risk
Pneumonia pseudomonal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumonia staphylococcal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumonia streptococcal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Post procedural infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Postoperative wound infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pseudomembranous colitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pulmonary tuberculosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pyelonephritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Pyelonephritis acute
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pyelonephritis chronic
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Salmonellosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Salpingitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Salpingo-oophoritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG00115 affected2,343 at risk
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0015 affected2,343 at risk
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Skin infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Small intestine gangrene
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Soft tissue infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Staphylococcal bacteraemia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Staphylococcal sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Stenotrophomonas infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Subcutaneous abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Subdural empyema
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tick-borne viral encephalitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tonsillitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tooth infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tracheitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tracheobronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tuberculosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tuberculosis of peripheral lymph nodes
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00013 affected2,206 at risk
EG00111 affected2,343 at risk
Urosepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0013 affected2,343 at risk
Vaginal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Vestibular neuronitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Viral infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Wound infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bone fissure
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Brain contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cataract traumatic
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0018 affected2,343 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Coronary artery restenosis
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Dislocation of vertebra
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Eye penetration
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0019 affected2,343 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00013 affected2,206 at risk
EG00116 affected2,343 at risk
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00016 affected2,206 at risk
EG00115 affected2,343 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00016 affected2,206 at risk
EG00112 affected2,343 at risk
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00014 affected2,206 at risk
EG00111 affected2,343 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Graft complication
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hand fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Head injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0016 affected2,343 at risk
Hip fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00013 affected2,206 at risk
EG0015 affected2,343 at risk
Ilium fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Injury corneal
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0016 affected2,343 at risk
Joint injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Ligament injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Limb crushing injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0013 affected2,343 at risk
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0012 affected2,343 at risk
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Patella fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0015 affected2,343 at risk
Perineal injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Postoperative hernia
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Procedural hypotension
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Pubis fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0015 affected2,343 at risk
Radiation mucositis
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00025 affected2,206 at risk
EG00122 affected2,343 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0014 affected2,343 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Scar
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Shunt malfunction
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Skeletal injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Skull fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0010 affected2,343 at risk
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG0011 affected2,343 at risk
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0019 affected2,343 at risk
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00017 affected2,206 at risk
EG00112 affected2,343 at risk
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Transplant dysfunction
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG0019 affected2,343 at risk
Ulnar nerve injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Antinuclear antibody positive
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Blood pressure increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Blood pressure orthostatic
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Carcinoembryonic antigen increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatic enzyme increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Investigation
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Occult blood positive
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Protein total decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Troponin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Cachexia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0017 affected2,343 at risk
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Failure to thrive
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Acquired claw toe
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected2,206 at risk
EG00115 affected2,343 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0014 affected2,343 at risk
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00016 affected2,206 at risk
EG00110 affected2,343 at risk
Bone disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bone loss
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0017 affected2,343 at risk
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00012 affected2,206 at risk
EG0017 affected2,343 at risk
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Kyphosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Morphoea
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Muscle disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0014 affected2,343 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Nodal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00079 affected2,206 at risk
EG00199 affected2,343 at risk
Osteoarthropathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0016 affected2,343 at risk
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0012 affected2,343 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Plica syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Seronegative arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected2,206 at risk
EG00122 affected2,343 at risk
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Spondyloarthropathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Synovial disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Adenosquamous cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Adrenal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Adrenal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00016 affected2,206 at risk
EG00114 affected2,343 at risk
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Benign gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Benign hepatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Benign neoplasm of bladder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign vulval neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Brain neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00021 affected2,206 at risk
EG00124 affected2,343 at risk
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Carcinoma in situ of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Central nervous system lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG00112 affected2,343 at risk
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Dermatofibrosarcoma protuberans
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Diffuse large B-cell lymphoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Follicular thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0015 affected2,343 at risk
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Gingival cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hairy cell leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hepatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Hepatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00010 affected2,206 at risk
EG0012 affected2,343 at risk
Invasive papillary breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Laryngeal papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Lentigo maligna
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Lip neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0013 affected2,343 at risk
Lung carcinoma cell type unspecified recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00011 affected2,206 at risk
EG00113 affected2,343 at risk
Lung squamous cell carcinoma stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0015 affected2,343 at risk
Malignant neoplasm of spinal cord
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Malignant peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Malignant urinary tract neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mantle cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Mesothelioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Metastatic carcinoma of the bladder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metastatic gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Metastatic squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Monoclonal gammopathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Muscle neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Myeloproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Nodular fasciitis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Non-Hodgkin's lymphoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0014 affected2,343 at risk
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Oral neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Ovarian cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ovarian cancer stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ovarian epithelial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Ovarian fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0015 affected2,343 at risk
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Pelvic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Phyllodes tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0014 affected2,343 at risk
Plasmacytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Polycythaemia vera
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Rectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Rectosigmoid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0014 affected2,343 at risk
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Tongue neoplasm malignant stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Ureteric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0012 affected2,343 at risk
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Vulval cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Acoustic neuritis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Akinesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Amnesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Amyotrophic lateral sclerosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Aphasia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0010 affected2,343 at risk
Ataxia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Carotid artery occlusion
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Carotid artery stenosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Carotid artery thrombosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Carpal tunnel syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0015 affected2,343 at risk
Cauda equina syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cerebellar haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cerebellar infarction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cerebral arteriosclerosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Cerebral artery embolism
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cerebral atrophy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0012 affected2,343 at risk
Cerebral infarction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG00117 affected2,343 at risk
Cerebral ischaemia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0016 affected2,343 at risk
Cerebral microangiopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cerebral thrombosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG0018 affected2,343 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00022 affected2,206 at risk
EG00129 affected2,343 at risk
Cerebrovascular disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Cerebrovascular insufficiency
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Cervicogenic headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Cognitive disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Coma
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Cubital tunnel syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Dementia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Dementia Alzheimer's type
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0015 affected2,343 at risk
Diabetic hyperosmolar coma
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Diabetic neuropathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0015 affected2,343 at risk
Dysaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Embolic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Epilepsy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Extrapyramidal disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Facial paresis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Haemorrhage intracranial
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Haemorrhagic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0013 affected2,343 at risk
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Hemiparesis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Hypertensive encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypotonia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Intercostal neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Intracranial aneurysm
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ischaemic cerebral infarction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ischaemic stroke
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected2,206 at risk
EG0019 affected2,343 at risk
Lacunar infarction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Loss of consciousness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Lumbar radiculopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Mental impairment
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Mononeuropathy multiplex
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Motor dysfunction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Motor neurone disease
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Myasthenia gravis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Nervous system disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Optic neuritis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Paraesthesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Parkinson's disease
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Parkinsonism
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Partial seizures
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Polyneuropathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Presyncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Pseudoradicular syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pyramidal tract syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Radicular syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Radiculitis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Radiculopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Sciatica
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG00112 affected2,343 at risk
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Senile dementia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Sensory disturbance
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Spinal cord compression
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00018 affected2,206 at risk
EG00120 affected2,343 at risk
Tarsal tunnel syndrome
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Thrombotic cerebral infarction
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Transient global amnesia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Transient ischaemic attack
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00021 affected2,206 at risk
EG00119 affected2,343 at risk
Trigeminal neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
VIIth nerve paralysis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Vascular dementia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Vascular headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Vertebrobasilar insufficiency
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Aggression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Anxiety
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Anxiety disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Completed suicide
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Confusional state
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0012 affected2,343 at risk
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected2,206 at risk
EG0019 affected2,343 at risk
Emotional distress
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hallucination
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Mental disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Psychotic disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Schizophrenia, paranoid type
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Suicide attempt
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0016 affected2,343 at risk
Bladder disorder
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Bladder irritation
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bladder prolapse
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0016 affected2,343 at risk
Calculus bladder
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Calculus ureteric
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0012 affected2,343 at risk
Calculus urethral
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Chronic kidney disease
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Cystitis interstitial
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Diabetic nephropathy
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Haematuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mixed incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Nephropathy
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Renal colic
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Renal failure
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0015 affected2,343 at risk
Stress urinary incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ureteric stenosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Urethral disorder
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Urethral stenosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Urge incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Urinary bladder polyp
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Urinary retention
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Breast mass
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Colpocele
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Cystocele
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected2,206 at risk
EG0015 affected2,343 at risk
Endometrial atrophy
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Endometrial metaplasia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Fibrocystic breast disease
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Genital prolapse
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Mammary duct ectasia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Metrorrhagia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Ovarian cyst
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0013 affected2,343 at risk
Rectocele
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0015 affected2,343 at risk
Uterine cyst
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Uterine polyp
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0014 affected2,343 at risk
Uterine prolapse
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected2,206 at risk
EG0019 affected2,343 at risk
Vaginal cyst
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Vaginal prolapse
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Vulval leukoplakia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0011 affected2,343 at risk
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Bronchomalacia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected2,206 at risk
EG0016 affected2,343 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0017 affected2,343 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0014 affected2,343 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Laryngeal cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Mediastinal cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0015 affected2,343 at risk
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00019 affected2,206 at risk
EG00113 affected2,343 at risk
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 affected2,206 at risk
EG0015 affected2,343 at risk
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0014 affected2,343 at risk
Tonsillar cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tracheomalacia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Lichen sclerosus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0015 affected2,343 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0011 affected2,343 at risk
Activities of daily living impaired
Social circumstances
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Physical assault
Social circumstances
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Anticoagulant therapy
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Arthrodesis
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Benign tumour excision
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Cardiac pacemaker replacement
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Chemotherapy
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hip arthroplasty
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Hospitalisation
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Hysterectomy
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Joint arthroplasty
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Knee arthroplasty
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Rehabilitation therapy
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Spinal decompression
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Tooth extraction
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Urethral operation
Surgical and medical procedures
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Accelerated hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Aortic aneurysm
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0015 affected2,343 at risk
Aortic dissection
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Aortic stenosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0018 affected2,343 at risk
Arterial disorder
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0012 affected2,343 at risk
Arterial haemorrhage
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Arterial occlusive disease
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Arteriosclerosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0015 affected2,343 at risk
Circulatory collapse
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected2,206 at risk
EG0011 affected2,343 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected2,206 at risk
EG0018 affected2,343 at risk
Embolism venous
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Essential hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Femoral artery aneurysm
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Femoral artery occlusion
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Haematoma
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Haemorrhage
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG00018 affected2,206 at risk
EG00121 affected2,343 at risk
Hypertensive crisis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected2,206 at risk
EG0013 affected2,343 at risk
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Hypovolaemic shock
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Intermittent claudication
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Ischaemia
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0013 affected2,343 at risk
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0012 affected2,343 at risk
Peripheral artery stenosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Peripheral embolism
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Peripheral ischaemia
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0013 affected2,343 at risk
Peripheral vascular disorder
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0010 affected2,343 at risk
Peripheral venous disease
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Phlebolith
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Shock haemorrhagic
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Subclavian artery occlusion
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Temporal arteritis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0013 affected2,343 at risk
Thrombophlebitis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0012 affected2,343 at risk
Thrombophlebitis superficial
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
Thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected2,206 at risk
EG0013 affected2,343 at risk
Varicose vein
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected2,206 at risk
EG0013 affected2,343 at risk
Vasculitis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected2,206 at risk
EG0011 affected2,343 at risk
Vasculitis necrotising
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected2,206 at risk
EG0011 affected2,343 at risk
Venous thrombosis limb
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected2,206 at risk
EG0010 affected2,343 at risk
EG000141 affected2,206 at risk
EG001168 affected2,343 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG000138 affected2,206 at risk
EG001140 affected2,343 at risk
Cataract
Eye disorders
MedDRA 18.0
Systematic Assessment
EG000319 affected2,206 at risk
EG001317 affected2,343 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG000141 affected2,206 at risk
EG001118 affected2,343 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG000139 affected2,206 at risk
EG001152 affected2,343 at risk
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000206 affected2,206 at risk
EG001226 affected2,343 at risk
Cystitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000194 affected2,206 at risk
EG001212 affected2,343 at risk
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000179 affected2,206 at risk
EG001192 affected2,343 at risk
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000372 affected2,206 at risk
EG001385 affected2,343 at risk
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000137 affected2,206 at risk
EG001167 affected2,343 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000139 affected2,206 at risk
EG001128 affected2,343 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG000242 affected2,206 at risk
EG001250 affected2,343 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG000181 affected2,206 at risk
EG001176 affected2,343 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG000240 affected2,206 at risk
EG001268 affected2,343 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG000215 affected2,206 at risk
EG001200 affected2,343 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG000527 affected2,206 at risk
EG001541 affected2,343 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG000501 affected2,206 at risk
EG001493 affected2,343 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG000197 affected2,206 at risk
EG001231 affected2,343 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG000332 affected2,206 at risk
EG001355 affected2,343 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG000264 affected2,206 at risk
EG001293 affected2,343 at risk
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG000173 affected2,206 at risk
EG001163 affected2,343 at risk
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG000121 affected2,206 at risk
EG001103 affected2,343 at risk
Sciatica
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG000149 affected2,206 at risk
EG001165 affected2,343 at risk
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG000135 affected2,206 at risk
EG001143 affected2,343 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG000172 affected2,206 at risk
EG001168 affected2,343 at risk
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG000460 affected2,206 at risk
EG001498 affected2,343 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
D014947
Wounds and Injuries
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
1
OG0010
High potassium - Grade 3
Title
Measurements
OG0009
OG00111
High potassium - Grade 4
Title
Measurements
OG0000
OG0013
Low potassium - Grade 3
Title
Measurements
OG0007
OG0017
Low magnesium - Grade 3
Title
Measurements
OG0001
OG0011
Low magnesium - Grade 4
Title
Measurements
OG0000
OG0011
High calcium - Grade 3
Title
Measurements
OG0002
OG0013
High calcium - Grade 4
Title
Measurements
OG0000
OG0012
High corrected calcium - Grade 3
Title
Measurements
OG0002
OG0013
High corrected calcium - Grade 4
Title
Measurements
OG0000
OG0012
Low phosphorus - Grade 3
Title
Measurements
OG0003
OG0011
High Creatinine - Grade 3
Title
Measurements
OG0000
OG0011
High aspartate amino transferase (AST) - Grade 3
Title
Measurements
OG0005
OG00111
High aspartate amino transferase (AST) - Grade 4
Title
Measurements
OG0001
OG0010
High alanine amino transferase (ALT) - Grade 3
Title
Measurements
OG0008
OG00110
High alanine amino transferase (ALT) - Grade 4
Title
Measurements
OG0001
OG0010
High total bilirubin - Grade 3
Title
Measurements
OG0002
OG0013
Low albumin - Grade 3
Title
Measurements
OG0000
OG0011
High glucose - Grade 3
Title
Measurements
OG00035
OG00137
High glucose - Grade 4
Title
Measurements
OG0000
OG0011
Low glucose - Grade 3
Title
Measurements
OG0004
OG0011
Low glucose - Grade 4
Title
Measurements
OG0001
OG0011
Low hemoglobin - Grade 3
Title
Measurements
OG0006
OG0014
Low platelets - Grade 3
Title
Measurements
OG0003
OG0017
Low platelets - Grade 4
Title
Measurements
OG0002
OG0014
Low white blood cells - Grade 3
Title
Measurements
OG0005
OG0017
Low white blood cells - Grade 4
Title
Measurements
OG0000
OG0011
Low lymphocytes - Grade 3
Title
Measurements
OG00017
OG00116
Low lymphocytes - Grade 4
Title
Measurements
OG0002
OG0011
7.7
(7.5 to 7.9)
OG0013.5(3.4 to 3.7)
Month 36 (n = 1497, 1607)
Title
Measurements
OG0009.4(9.1 to 9.6)
OG0014.9(4.7 to 5.1)
Month 60 (n = 1472, 1567)
Title
Measurements
OG00013.0(12.7 to 13.3)
OG0017.9(7.6 to 8.2)
Month 84 (n = 1223, 1264)
Title
Measurements
OG00016.5(16.1 to 16.9)
OG00110.8(10.4 to 11.2)
4.1
(4.0 to 4.2)
OG0011.4(1.3 to 1.5)
Month 36 (n = 1475, 1591)
Title
Measurements
OG0004.9(4.7 to 5.0)
OG0011.8(1.7 to 2.0)
Month 60 (n = 1439, 1538)
Title
Measurements
OG0006.2(6.0 to 6.4)
OG0012.6(2.4 to 2.8)
Month 84 (n = 1200, 1232)
Title
Measurements
OG0007.4(7.1 to 7.6)
OG0013.4(3.2 to 3.7)
3.2
(3.1 to 3.4)
OG0011.2(1.0 to 1.4)
Month 36 (n = 1475, 1591)
Title
Measurements
OG0004.0(3.8 to 4.3)
OG0011.7(1.5 to 1.9)
Month 60 (n = 1439, 1538)
Title
Measurements
OG0005.7(5.4 to 5.9)
OG0012.8(2.6 to 3.1)
Month 84 (n = 1200, 1232)
Title
Measurements
OG0007.1(6.8 to 7.4)
OG0013.8(3.5 to 4.2)
0.2
(-0.4 to 0.9)
OG0010.2(-0.4 to 0.8)
Month 36 (n = 73, 93)
Title
Measurements
OG0001.3(0.5 to 2.0)
OG0010.6(-0.1 to 1.3)
Month 60 (n = 59, 84)
Title
Measurements
OG0001.8(0.9 to 2.7)
OG0011.4(0.6 to 2.2)
Month 84 (n = 39, 56)
Title
Measurements
OG0002.2(0.9 to 3.6)
OG0011.0(-0.1 to 2.2)
8.4
(8.1 to 8.7)
OG00113.7(13.4 to 13.9)
Month 36 (n = 1487, 1589)
Title
Measurements
OG00010.1(9.8 to 10.4)
OG00115.2(14.9 to 15.5)
Month 60 (n = 1464, 1551)
Title
Measurements
OG00013.8(13.4 to 14.1)
OG00118.4(18.1 to 18.8)
Month 84 (n = 1216, 1251)
Title
Measurements
OG00017.3(16.8 to 17.8)
OG00121.7(21.2 to 22.2)
2.9
(2.7 to 3.0)
OG0017.1(6.9 to 7.2)
Month 36 (n = 1457, 1567)
Title
Measurements
OG0003.6(3.4 to 3.8)
OG0017.5(7.3 to 7.7)
Month 60 (n = 1424, 1518)
Title
Measurements
OG0004.9(4.7 to 5.2)
OG0018.4(8.1 to 8.6)
Month 84 (n = 1189, 1215)
Title
Measurements
OG0006.1(5.8 to 6.4)
OG0019.2(8.9 to 9.5)
2.6
(2.3 to 2.8)
OG0016.2(6.0 to 6.5)
Month 36 (n = 1457, 1567)
Title
Measurements
OG0003.4(3.1 to 3.6)
OG0016.7(6.5 to 7.0)
Month 60 (n = 1424, 1518)
Title
Measurements
OG0005.0(4.7 to 5.3)
OG0017.9(7.6 to 8.2)
Month 84 (n = 1189, 1215)
Title
Measurements
OG0006.4(6.0 to 6.8)
OG0019.0(8.6 to 9.4)
-1.2
(-1.9 to -0.4)
OG0012.1(1.4 to 2.8)
Month 36 (n = 73, 92)
Title
Measurements
OG000-0.2(-1.1 to 0.7)
OG0012.4(1.6 to 3.2)
Month 60 (n = 59, 83)
Title
Measurements
OG0000.3(-0.7 to 1.3)
OG0013.3(2.4 to 4.2)
Month 84 (n = 39, 56)
Title
Measurements
OG0000.6(-0.8 to 2.1)
OG0012.8(1.6 to 4.1)
-85
(-91 to -73)
OG001-26(-63 to 1)
Month 12 (n = 27, 56)
Title
Measurements
OG000-75(-90 to -54)
OG001-13(-37 to 24)
Month 24 (n = 27, 47)
Title
Measurements
OG000-67(-84 to -29)
OG00110(-27 to 55)
Month 36 (n = 68, 81)
Title
Measurements
OG000-59(-84 to -28)
OG0012(-32 to 68)
Month 48 (n = 62, 75)
Title
Measurements
OG000-58(-84 to -12)
OG0010(-46 to 56)
Month 60 (n = 59, 70)
Title
Measurements
OG000-65(-90 to -19)
OG0010(-47 to 83)
Month 72 (n = 56, 62)
Title
Measurements
OG000-60(-85 to -16)
OG001-1(-47 to 76)
Month 84 (n = 41, 41)
Title
Measurements
OG000-64(-86 to -28)
OG001-6(-26 to 68)
-71
(-78 to -62)
OG001-23(-50 to -2)
Month 12 (n = 26, 56)
Title
Measurements
OG000-67(-76 to -57)
OG0017(-15 to 30)
Month 24 (n = 27, 47)
Title
Measurements
OG000-63(-77 to -41)
OG00111(-17 to 42)
Month 36 (n = 69, 83)
Title
Measurements
OG000-57(-67 to -29)
OG00129(-6 to 91)
Month 48 (n = 61, 73)
Title
Measurements
OG000-60(-70 to -41)
OG0018(-21 to 49)
Month 60 (n = 61, 71)
Title
Measurements
OG000-54(-72 to -35)
OG00130(-6 to 67)
Month 72 (n = 55, 64)
Title
Measurements
OG000-50(-60 to -36)
OG00144(3 to 103)
Month 84 (n = 48, 50)
Title
Measurements
OG000-59(-73 to -40)
OG00132(-4 to 75)
-83
(-90 to -72)
OG001-77(-87 to -49)
Month 12 (n = 27, 65)
Title
Measurements
OG000-77(-91 to -45)
OG001-63(-87 to -11)
Month 24 (n = 28, 60)
Title
Measurements
OG000-65(-80 to -24)
OG001-53(-82 to 0)
Month 36 (n = 289, 313)
Title
Measurements
OG000-71(-88 to -40)
OG001-52(-86 to -4)
Month 48 (n = 274, 290)
Title
Measurements
OG000-70(-88 to -36)
OG001-61(-85 to -24)
Month 60 (n = 268, 276)
Title
Measurements
OG000-67(-88 to -25)
OG001-53(-86 to -18)
Month 72 (n = 243, 248)
Title
Measurements
OG000-69(-88 to -32)
OG001-59(-86 to -21)
Month 84 (n = 217, 216)
Title
Measurements
OG000-63(-88 to -19)
OG001-53(-84 to -12)
-74
(-80 to -67)
OG001-75(-80 to -55)
Month 12 (n = 26, 56)
Title
Measurements
OG000-74(-79 to -51)
OG001-63(-76 to -36)
Month 24 (n = 28, 51)
Title
Measurements
OG000-67(-75 to -51)
OG001-56(-72 to -30)
Month 36 (n = 70, 83)
Title
Measurements
OG000-59(-75 to -37)
OG001-60(-71 to -40)
Month 48 (n = 61, 73)
Title
Measurements
OG000-67(-75 to -46)
OG001-63(-77 to -42)
Month 60 (n = 61, 71)
Title
Measurements
OG000-62(-75 to -42)
OG001-55(-74 to -30)
Month 72 (n = 56, 67)
Title
Measurements
OG000-62(-71 to -35)
OG001-55(-70 to -27)
Month 84 (n =49, 53)
Title
Measurements
OG000-68(-78 to -56)
OG001-57(-74 to -38)
5890
± 2010
OG0016010± 2530
Month 3 (n = 81, 92)
Title
Measurements
OG0001000± 560
OG0011190± 690
Month 4 (n = 87, 104)
Title
Measurements
OG000429± 378
OG001554± 480
Month 6 (n = 87, 103)
Title
Measurements
OG00020.8± 61.7
OG00166.0± 147.2
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG00116.358± 4.438
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0011.235± 0.254
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG001708.669± 171.782
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG001132.965± 28.064
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG001786.19± 279.81
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG00117.631± 4.387
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0012.472± 0.506
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0015.951± 15.223
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.421± 1.068
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0014.108± 3.476
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG00139.59± 7.49
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.511± 0.579
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.074± 0.101
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0017.4± 10.1
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.077± 0.107
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0017.7± 10.7
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.611± 0.726
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.106± 0.237
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.412± 0.458
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.394± 0.233
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.818± 1.207
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.691± 0.868
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0011.071± 1.308
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG001229.7± 512.0
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.014± 0.024
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84
OG0010.048± 0.133
NA
± NA
No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84