Determine the Efficacy, Safety and Tolerability of Denosu... | NCT00043186 | Trialant
NCT00043186
Sponsor
Amgen
Status
Completed
Last Update Posted
Sep 18, 2013Estimated
Enrollment
412Actual
Phase
Phase 2
Conditions
Low Bone Mineral Density
Interventions
Placebo
Denosumab
Alendronate
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
NCT00043186
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20010223
Secondary IDs
Not provided
Brief Title
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Official Title
A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Sep 2013
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
May 2002
Primary Completion Date
Apr 2007Actual
Completion Date
Jun 2007Actual
First Submitted Date
Aug 6, 2002
First Submission Date that Met QC Criteria
Aug 6, 2002
First Posted Date
Aug 7, 2002Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2009
Results First Submitted that Met QC Criteria
Jun 25, 2010
Results First Posted Date
Jul 28, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 23, 2009
Certification/Extension First Submitted that Passed QC Review
Nov 23, 2009
Certification/Extension First Posted Date
Nov 25, 2009Estimated
Last Update Submitted Date
Sep 6, 2013
Last Update Posted Date
Sep 18, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
Detailed Description
Not provided
Conditions Module
Conditions
Low Bone Mineral Density
Keywords
bone loss
osteoporosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
412Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
Drug: Placebo
Denosumab 6 mg every 3 months
Experimental
Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab 14 mg every 3 months
Experimental
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab 30 mg every 3 months
Experimental
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
Drug: Denosumab
Denosumab 14 mg every 6 months
Experimental
Participants received denosumab 14 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo subcutaneous injection
Placebo
Denosumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Secondary Outcomes
Measure
Description
Time Frame
Serum CTX Percent Change From Baseline at Month 12
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Urine NTX/Creatinine Percent Change From Baseline at Month 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
women not more than 80 years of age on date of randomization
≥ 1 year postmenopausal on date of randomization
ambulatory
if ≤ 60 years of age, or had or would require a bilateral oophorectomy, serum follicle stimulating hormone (FSH) > 50 mU/mL or serum estradiol < 20 pg/mL
low BMD (BMD T-score ≤ -1.8 at any 1 of the following sites: lumbar spine, femoral neck, or total hip; BMD T-scores must not have been < -4.0 at the lumbar spine or - 3.5 at the femoral neck or total hip)
before any study-specific procedure, including the screening dual X-ray absorptiometry (DXA) scan, gave informed consent for participation in the study.
Exclusion Criteria
fluoride treatment for osteoporosis within the 2 years before the enrollment date
bisphosphonate use within the 12 months before the enrollment date
administration of the following medications within the 6 months before the enrollment date
tibolone
Parathyroid hormone (PTH) (or any derivative)
systemic glucocorticosteroids (> 5 mg oral prednisone equivalent per day for > 10 days)
inhaled corticosteroids (> 2000 μg per day for > 10 days)
anabolic steroids or testosterone
administration of the following medications within the 3 months before the enrollment date
systemic hormone replacement therapy
selective estrogen receptor modulators
calcitonin
calcitriol
current hyper- or hypothyroidism (allowed if stable on thyroid replacement therapy and thyroid-stimulating hormone was within the normal range)
any bone disease, other than osteoporosis, which could interfere with the interpretation of the findings (eg, osteogenesis imperfecta or osteopetrosis)
malabsorption syndrome
weight, height, or girth that could preclude accurate DXA measurements
< 2 lumbar vertebrae (L1 through L4) evaluable by DXA
recent long bone fracture (within 6 months)
osteoporotic-related fracture (ie, crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 2 years of randomization
> 1 single, grade 1 vertebral fracture
currently enrolled in or had participated within the previous 30 days in other investigational device or drug trial(s) (For some trials, this may have been allowed after discussion and written approval from Amgen.)
known sensitivity to mammalian-derived drug preparations (eg, Herceptin®)
any organic or psychiatric disorder, serum chemistry, or hematology that, in the opinion of the investigator, could have prevented the subject from completing the study or have interfered with the interpretation of the study results
self-reported alcohol or drug abuse within the previous 12 months
any disorder that compromised the ability to give truly informed consent for participation in the study
previous administration of denosumab
known sensitivity or contraindication to alendronate
known sensitivity or contraindication to tetracycline derivatives (subjects in the biopsy substudy only).
Beck TJ, Lewiecki EM, Miller PD, Felsenberg D, Liu Y, Ding B, Libanati C. Effects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronate. J Clin Densitom. 2008 Jul-Sep;11(3):351-9. doi: 10.1016/j.jocd.2008.04.001. Epub 2008 May 20.
Lewiecki EM, Miller PD, McClung MR, Cohen SB, Bolognese MA, Liu Y, Wang A, Siddhanti S, Fitzpatrick LA; AMG 162 Bone Loss Study Group. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res. 2007 Dec;22(12):1832-41. doi: 10.1359/jbmr.070809.
First Subject Enrolled: 11-May-2002 Last Subject Enrolled: 30-Apr-2003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
FG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
FG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
FG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
FG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
FG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
FG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
FG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
FG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00046 subjects
FG00144 subjects
FG00244 subjects
FG00341 subjects
FG00454 subjects
FG00547 subjects
FG00642 subjects
FG00747 subjects
FG00847 subjects
COMPLETED
FG00029 subjects
FG00129 subjects
FG00224 subjects
FG00319 subjects
FG004
NOT COMPLETED
FG00017 subjects
FG00115 subjects
FG00220 subjects
FG00322 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
BG001
Denosumab 6 mg Q3M
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
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and Month 12
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Adverse Events Module
Frequency Threshold
5
Time Frame
48 months
Description
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
Participants received denosumab 60 mg SC every 6 months until Month 42.
Drug: Denosumab
Denosumab 100 mg every 6 months
Experimental
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
Drug: Denosumab
Denosumab 210 mg every 6 months
Experimental
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
Drug: Denosumab
Alendronate 70 mg
Active Comparator
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Drug: Alendronate
Drug
Denosumab for subcutaneous injection
Denosumab 100 mg every 6 months
Denosumab 14 mg every 3 months
Denosumab 14 mg every 6 months
Denosumab 210 mg every 6 months
Denosumab 30 mg every 3 months
Denosumab 6 mg every 3 months
Denosumab 60 mg every 6 months
AMG 162
Prolia
Alendronate
Drug
Alendronate 70 mg tablets
Alendronate 70 mg
Fosamax
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and Month 12
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Serum CTX Percent Change From Baseline at Month 24
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Serum CTX Percent Change From Baseline at Month 36
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Serum CTX Percent Change From Baseline at Month 42
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Serum CTX Percent Change From Baseline at Month 48
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Urine NTX/Creatinine Percent Change From Baseline at Month 24
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Urine NTX/Creatinine Percent Change From Baseline at Month 36
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Urine NTX/Creatinine Percent Change From Baseline at Month 42
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Urine NTX/Creatinine Percent Change From Baseline at Month 48
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Total Hip Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Total Body Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Baseline and 48 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Baseline and 12 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Baseline and 24 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Baseline and 36 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Baseline and 42 months
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH, Lain D, Kivitz AJ, Holloway DL, Zhang C, Peterson MC, Bekker PJ; AMG 162 Bone Loss Study Group. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med. 2006 Feb 23;354(8):821-31. doi: 10.1056/NEJMoa044459.
Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.
Peterson MC, Riggs MM. A physiologically based mathematical model of integrated calcium homeostasis and bone remodeling. Bone. 2010 Jan;46(1):49-63. doi: 10.1016/j.bone.2009.08.053. Epub 2009 Sep 2.
36 subjects
FG00539 subjects
FG00625 subjects
FG00731 subjects
FG00830 subjects
18 subjects
FG0058 subjects
FG00617 subjects
FG00716 subjects
FG00817 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
Adverse Event
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0083 subjects
Withdrawal by Subject
FG00011 subjects
FG0018 subjects
FG00211 subjects
FG00313 subjects
FG00414 subjects
FG0056 subjects
FG00612 subjects
FG0079 subjects
FG00810 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
Disease progression
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0074 subjects
FG0080 subjects
Ineligibility determined
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Lost to Follow-up
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
Noncompliance
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
BG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
BG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
BG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
BG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
BG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
BG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
BG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
BG009
Total
Total of all reporting groups
46
BG00144
BG00244
BG00341
BG00454
BG00547
BG00642
BG00747
BG00847
BG009412
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00063.7± 9.1
BG00162.8± 8.6
BG00262.3± 6
BG00361.2± 8.5
BG00461.4± 8.1
BG00563.1± 8.1
BG00664.9± 8.2
BG00760.5± 7.8
BG00862.8± 8.2
BG00962.5± 8.1
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00046
BG00144
BG00244
BG00341
BG00454
BG00547
BG00642
BG00747
BG00847
BG009412
Male
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White or Caucasian
Title
Measurements
BG00037
BG00133
BG00242
BG00336
BG00449
BG00539
BG00637
BG00742
BG00840
BG009355
Black or African American
Title
Measurements
BG0000
BG0011
BG0021
BG003
Hispanic or Latino
Title
Measurements
BG0008
BG0018
BG0021
BG003
Asian
Title
Measurements
BG0001
BG0011
BG0020
BG003
Japanese
Title
Measurements
BG0000
BG0010
BG0020
BG003
American Indian or Alaska Native
Title
Measurements
BG0000
BG0011
BG0020
BG003
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
Units
Counts
Participants
OG00040
OG00136
OG00236
OG00332
OG00448
OG00541
OG00637
OG00741
Title
Denominators
Categories
Title
Measurements
OG000-0.81± 0.48
OG0014.41± 0.50
OG0024.71± 0.50
OG0036.69± 0.54
OG0043.03± 0.43
OG0054.55± 0.47
OG0065.52± 0.49
OG0075.07± 0.47
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG007
ANCOVA
<0.001
Mean Difference (Final Values)
5.87
95
4.59
7.16
No
Superiority or Other
OG000
OG006
ANCOVA
<0.001
Mean Difference (Final Values)
6.33
95
5.01
7.65
No
Superiority or Other
OG000
OG005
ANCOVA
<0.001
Mean Difference (Final Values)
5.35
95
4.07
6.64
No
Superiority or Other
OG000
OG004
ANCOVA
<0.001
Mean Difference (Final Values)
3.84
95
2.60
5.07
No
Superiority or Other
OG000
OG003
ANCOVA
<0.001
Mean Difference (Final Values)
7.50
95
6.13
8.87
No
Superiority or Other
OG000
OG002
ANCOVA
<0.001
Mean Difference (Final Values)
5.52
95
4.19
6.85
No
Superiority or Other
OG000
OG001
ANCOVA
<0.001
Mean Difference (Final Values)
5.21
95
3.88
6.55
No
Superiority or Other
Secondary
Serum CTX Percent Change From Baseline at Month 12
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12
Posted
Median
Inter-Quartile Range
Percent change
Baseline and Month 12
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00036
OG00135
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.699(-20.74 to 28.3)
OG001-61.366(-74.42 to -41.92)
OG002-77.989(-87.02 to -55.37)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Urine NTX/Creatinine Percent Change From Baseline at Month 12
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and Month 12
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00036
OG00135
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG00024.300(-23.06 to 39.84)
OG001-40.018(-49.76 to -6.38)
OG002-54.688(-66.80 to -23.33)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and Month 12
ID
Title
Description
OG000
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00045
Title
Denominators
Categories
Title
Measurements
OG0004.59± 0.45
Secondary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00034
OG00132
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.25± 0.68
OG0017.42± 0.69
OG0027.21± 0.68
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
7.34
95
5.56
9.12
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00030
OG00131
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.80± 0.82
OG0018.57± 0.80
OG0029.17± 0.89
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
6.50
95
4.32
8.67
No
Superiority or Other
OG000
OG007
ANCOVA
0.013
Secondary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG0008
OG0015
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.09± 1.70
OG0017.21± 2.13
OG00210.04± 1.86
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.02
Mean Difference (Final Values)
5.42
95
0.89
9.95
No
Superiority or Other
OG000
OG007
ANCOVA
0.992
Secondary
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00129
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.39± 1.11
OG0019.35± 1.09
OG0029.93± 1.20
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
6.93
95
3.97
9.89
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Serum CTX Percent Change From Baseline at Month 24
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00032
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.940(-23.22 to 20.61)
OG001-50.687(-73.73 to -27.21)
OG002-74.078(-84.96 to -52.32)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Serum CTX Percent Change From Baseline at Month 36
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00130
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-16.577(-28.96 to -0.29)
OG001-62.298(-81.94 to -42.09)
OG002-53.643(-82.23 to -34.04)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.011
No
Superiority or Other
OG000
OG006
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Serum CTX Percent Change From Baseline at Month 42
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participantswith non-missing Baseline and non-missing value at Month 42.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00023
OG00127
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG000-16.279(-31.66 to 18.31)
OG001-63.543(-83.99 to -38.15)
OG002-40.827(-85.17 to -13.72)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG003
Wilcoxon (Mann-Whitney)
0.012
Secondary
Serum CTX Percent Change From Baseline at Month 48
Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00027
OG00129
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-14.561(-33.09 to 6.61)
OG001-40.016(-80.76 to 0.11)
OG002-34.999(-78.25 to -7.84)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.015
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
0.050
Secondary
Urine NTX/Creatinine Percent Change From Baseline at Month 24
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00032
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.422(-5.30 to 56.37)
OG001-19.699(-51.71 to 1.61)
OG002-37.691(-60.65 to -4.19)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Urine NTX/Creatinine Percent Change From Baseline at Month 36
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00130
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.508(-21.60 to 11.89)
OG001-33.294(-56.03 to -3.63)
OG002-47.752(-58.74 to -16.01)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.011
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Urine NTX/Creatinine Percent Change From Baseline at Month 42
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00024
OG00127
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG000-18.102(-31.05 to 30.83)
OG001-40.741(-60.82 to -12.95)
OG002-40.043(-65.63 to -9.12)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Wilcoxon (Mann-Whitney)
0.053
No
Superiority or Other
OG000
OG001
Wilcoxon (Mann-Whitney)
0.053
Secondary
Urine NTX/Creatinine Percent Change From Baseline at Month 48
Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00027
OG00128
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.064(-36.94 to 32.77)
OG001-23.311(-62.33 to 11.43)
OG002-38.002(-67.11 to -15.91)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.010
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
0.172
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 12 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00040
OG00136
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.56± 0.37
OG0012.89± 0.38
OG0022.45± 0.39
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
2.67
95
1.70
3.64
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00035
OG00132
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.92± 0.44
OG0014.04± 0.45
OG0023.55± 0.44
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
5.19
95
4.04
6.34
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00030
OG00131
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.84± 0.60
OG0014.79± 0.58
OG0024.41± 0.65
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
3.78
95
2.19
5.36
No
Superiority or Other
OG000
OG007
ANCOVA
0.07
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG0008
OG0015
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.96± 1.16
OG0015.01± 1.43
OG0023.98± 1.28
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.002
Mean Difference (Final Values)
4.94
95
1.86
8.02
No
Superiority or Other
OG000
OG007
ANCOVA
0.677
Secondary
Total Hip Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00129
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.52± 0.65
OG0015.45± 0.63
OG0024.03± 0.70
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
4.69
95
2.97
6.41
No
Superiority or Other
OG000
OG007
ANCOVA
0.015
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 12 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00039
OG00135
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.97± 0.50
OG0010.89± 0.52
OG0020.40± 0.53
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.033
Mean Difference (Final Values)
1.44
95
0.11
2.76
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00034
OG00132
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.78± 0.56
OG0011.31± 0.57
OG0020.62± 0.58
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.009
Mean Difference (Final Values)
1.99
95
0.49
3.49
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00131
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.64± 0.63
OG0011.99± 0.60
OG0021.06± 0.69
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.002
Mean Difference (Final Values)
2.69
95
1.01
4.38
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.59± 3.00
OG0011.00± 3.26
OG0020.82± 2.92
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
0.496
Mean Difference (Final Values)
3.27
95
-7.16
13.7
No
Superiority or Other
OG000
OG006
ANCOVA
0.527
Secondary
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing baseline and non-missing value at Month 48.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00028
OG00129
OG00222
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.67± 0.75
OG0011.04± 0.73
OG0021.42± 0.84
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
ANCOVA
<0.001
Mean Difference (Final Values)
6.41
95
4.48
8.34
No
Superiority or Other
OG000
OG003
ANCOVA
<0.001
Secondary
Total Body Bone Mineral Density Percent Change From Baseline at Month 12
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 12 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00036
OG00136
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.21± 0.46
OG0011.82± 0.45
OG0021.80± 0.46
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG007
ANCOVA
0.001
Mean Difference (Final Values)
2.30
95
1.09
3.51
No
Superiority or Other
OG000
OG008
ANCOVA
0.005
Secondary
Total Body Bone Mineral Density Percent Change From Baseline at Month 24
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00033
OG00131
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.64± 0.53
OG0012.59± 0.54
OG0022.91± 0.53
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
3.14
95
1.71
4.56
No
Superiority or Other
OG000
OG007
ANCOVA
<0.001
Secondary
Total Body Bone Mineral Density Percent Change From Baseline at Month 36
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00028
OG00131
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.61± 0.94
OG0013.14± 0.88
OG0023.04± 0.98
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
6.16
95
3.63
8.68
No
Superiority or Other
OG000
OG007
ANCOVA
0.275
Secondary
Total Body Bone Mineral Density Percent Change From Baseline at Month 42
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.61± 1.76
OG0011.90± 3.71
OG0024.05± 1.70
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
ANCOVA
0.949
Mean Difference (Final Values)
2.18
95
-8.73
13.10
No
Superiority or Other
OG000
OG005
ANCOVA
0.949
Secondary
Total Body Bone Mineral Density Percent Change From Baseline at Month 48
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00028
OG00128
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.54± 0.99
OG0013.68± 0.98
OG0023.38± 1.07
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
ANCOVA
<0.001
Mean Difference (Final Values)
7.02
95
4.35
9.69
No
Superiority or Other
OG000
OG007
ANCOVA
0.092
Secondary
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 12.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 12 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00036
OG00135
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.609(-26.46 to 30.31)
OG001-62.716(-77.57 to -47.64)
OG002-60.098(-76.61 to -41.34)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 24.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 24 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00032
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.464(-20.18 to 52.94)
OG001-41.225(-65.61 to -22.04)
OG002-47.597(-69.11 to -16.28)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
<0.001
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
<0.001
Secondary
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 36.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 36 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00029
OG00129
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.955(-28.21 to 45.67)
OG001-39.012(-66.11 to -12.10)
OG002-56.021(-69.45 to -21.31)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.049
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
0.008
Secondary
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 42.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 42 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00024
OG00127
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.288(-25.01 to 51.68)
OG001-40.182(-65.62 to -11.21)
OG002-40.819(-64.78 to -6.13)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.061
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
0.058
Secondary
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48
Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.
Randomized participants with non-missing Baseline and non-missing value at Month 48.
Posted
Median
Inter-Quartile Range
Percent change
Baseline and 48 months
ID
Title
Description
OG000
Placebo
Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
OG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
OG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
OG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
OG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
OG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Units
Counts
Participants
OG00027
OG00129
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.122(-28.72 to 59.58)
OG001-34.727(-56.34 to 3.83)
OG002-45.779(-60.49 to 9.42)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG008
Wilcoxon (Mann-Whitney)
0.142
No
Superiority or Other
OG000
OG007
Wilcoxon (Mann-Whitney)
0.218
5
46
43
46
EG001
Denosumab 6 mg Q3M
Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
7
43
38
43
EG002
Denosumab 14 mg Q3M
Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
13
44
39
44
EG003
Denosumab 30 mg Q3M
Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
9
40
35
40
EG004
Denosumab 14 mg Q6M
Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
7
53
44
53
EG005
Denosumab 60 mg Q6M
Participants received denosumab 60 mg SC every 6 months until Month 42.
5
47
42
47
EG006
Denosumab 100 mg Q6M
Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
9
41
38
41
EG007
Denosumab 210 mg Q6M
Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
6
46
41
46
EG008
Alendronate 70 mg
Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
8
46
42
46
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Angina pectoris
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0012 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Aortic valve stenosis
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Arrhythmia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Atrial flutter
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Bradycardia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Coronary artery disease
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Coronary artery stenosis
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Myocardial infarction
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Pericardial effusion
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Sick sinus syndrome
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Abdominal strangulated hernia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Non-cardiac chest pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Pyrexia
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Soft tissue inflammation
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Gallbladder disorder
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Appendicitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Bacteraemia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Bronchopneumonia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Catheter site cellulitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Diverticulitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Labyrinthitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Pneumonia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Pneumonia primary atypical
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Urinary tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Lung injury
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Diabetes mellitus non-insulin-dependent
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0042 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0022 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Follicle centre lymphoma, follicular grade I, II, III stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Hypergammaglobulinaemia benign monoclonal
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Ovarian epithelial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Carotid artery stenosis
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Cerebral haemorrhage
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Convulsion
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Lacunar infarction
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Neurological symptom
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Syncope
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Alcoholism
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Bladder prolapse
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Adenomyosis
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Bronchial hyperactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Colostomy closure
Surgical and medical procedures
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Hypotension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Thrombosis
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0085 affected46 at risk
Palpitations
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0043 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Blepharitis
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Cataract
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0023 affected44 at risk
EG0033 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0064 affected41 at risk
EG0072 affected46 at risk
EG0083 affected46 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0034 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0014 affected43 at risk
EG0021 affected44 at risk
EG0032 affected40 at risk
EG0041 affected53 at risk
EG0053 affected47 at risk
EG0063 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0052 affected47 at risk
EG0063 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0062 affected41 at risk
EG0070 affected46 at risk
EG0083 affected46 at risk
Constipation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0013 affected43 at risk
EG0021 affected44 at risk
EG0032 affected40 at risk
EG0045 affected53 at risk
EG0055 affected47 at risk
EG0063 affected41 at risk
EG0071 affected46 at risk
EG0086 affected46 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0006 affected46 at risk
EG0015 affected43 at risk
EG0025 affected44 at risk
EG0033 affected40 at risk
EG0043 affected53 at risk
EG0051 affected47 at risk
EG0066 affected41 at risk
EG0075 affected46 at risk
EG0084 affected46 at risk
Diverticulum
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0083 affected46 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0015 affected43 at risk
EG0025 affected44 at risk
EG0031 affected40 at risk
EG00412 affected53 at risk
EG0056 affected47 at risk
EG0066 affected41 at risk
EG0074 affected46 at risk
EG00812 affected46 at risk
Flatulence
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0042 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0073 affected46 at risk
EG0082 affected46 at risk
Gastritis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0042 affected53 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0073 affected46 at risk
EG0082 affected46 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0018 affected43 at risk
EG0022 affected44 at risk
EG0035 affected40 at risk
EG0048 affected53 at risk
EG0058 affected47 at risk
EG0064 affected41 at risk
EG0075 affected46 at risk
EG0087 affected46 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0012 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Hiatus hernia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0071 affected46 at risk
EG0082 affected46 at risk
Nausea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected43 at risk
EG0026 affected44 at risk
EG0036 affected40 at risk
EG0046 affected53 at risk
EG0055 affected47 at risk
EG0063 affected41 at risk
EG0079 affected46 at risk
EG00810 affected46 at risk
Stomach discomfort
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0083 affected46 at risk
Toothache
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0013 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0073 affected46 at risk
EG0082 affected46 at risk
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected43 at risk
EG0022 affected44 at risk
EG0033 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0082 affected46 at risk
Chills
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Fatigue
General disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0013 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0044 affected53 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0074 affected46 at risk
EG0082 affected46 at risk
Influenza like illness
General disorders
MedDRA 9.0
Systematic Assessment
EG0005 affected46 at risk
EG0014 affected43 at risk
EG0024 affected44 at risk
EG0033 affected40 at risk
EG00410 affected53 at risk
EG00511 affected47 at risk
EG0066 affected41 at risk
EG0073 affected46 at risk
EG0087 affected46 at risk
Injection site bruising
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0080 affected46 at risk
Injection site erythema
General disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Oedema peripheral
General disorders
MedDRA 9.0
Systematic Assessment
EG0005 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0034 affected40 at risk
EG0042 affected53 at risk
EG0054 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0083 affected46 at risk
Pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0024 affected44 at risk
EG0031 affected40 at risk
EG0042 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0083 affected46 at risk
Hypersensitivity
Immune system disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0012 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Seasonal allergy
Immune system disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected43 at risk
EG0022 affected44 at risk
EG0034 affected40 at risk
EG0043 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0072 affected46 at risk
EG0081 affected46 at risk
Bronchitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0005 affected46 at risk
EG0012 affected43 at risk
EG0021 affected44 at risk
EG00310 affected40 at risk
EG0044 affected53 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0075 affected46 at risk
EG0084 affected46 at risk
Dental caries
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Diverticulitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Ear infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0032 affected40 at risk
EG0043 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Gastroenteritis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0082 affected46 at risk
Gastroenteritis viral
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0064 affected41 at risk
EG0072 affected46 at risk
EG0083 affected46 at risk
Herpes zoster
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0022 affected44 at risk
EG0030 affected40 at risk
EG0042 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0080 affected46 at risk
Nasopharyngitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0007 affected46 at risk
EG00111 affected43 at risk
EG0029 affected44 at risk
EG0034 affected40 at risk
EG0044 affected53 at risk
EG00511 affected47 at risk
EG00611 affected41 at risk
EG00710 affected46 at risk
EG0086 affected46 at risk
Pneumonia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0053 affected47 at risk
EG0062 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Sinusitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0009 affected46 at risk
EG0014 affected43 at risk
EG0022 affected44 at risk
EG0036 affected40 at risk
EG00410 affected53 at risk
EG0056 affected47 at risk
EG0067 affected41 at risk
EG0072 affected46 at risk
EG0086 affected46 at risk
Tooth infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0020 affected44 at risk
EG0031 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG00011 affected46 at risk
EG00115 affected43 at risk
EG00210 affected44 at risk
EG0038 affected40 at risk
EG00413 affected53 at risk
EG00516 affected47 at risk
EG0068 affected41 at risk
EG00718 affected46 at risk
EG00814 affected46 at risk
Urinary tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected43 at risk
EG0024 affected44 at risk
EG0038 affected40 at risk
EG0045 affected53 at risk
EG0056 affected47 at risk
EG0065 affected41 at risk
EG0078 affected46 at risk
EG0086 affected46 at risk
Viral infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0044 affected53 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0014 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0012 affected43 at risk
EG0021 affected44 at risk
EG0036 affected40 at risk
EG0045 affected53 at risk
EG0054 affected47 at risk
EG0066 affected41 at risk
EG0076 affected46 at risk
EG0081 affected46 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0072 affected46 at risk
EG0081 affected46 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected43 at risk
EG0021 affected44 at risk
EG0035 affected40 at risk
EG0041 affected53 at risk
EG0055 affected47 at risk
EG0064 affected41 at risk
EG0071 affected46 at risk
EG0083 affected46 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0022 affected44 at risk
EG0032 affected40 at risk
EG0042 affected53 at risk
EG0054 affected47 at risk
EG0061 affected41 at risk
EG0074 affected46 at risk
EG0081 affected46 at risk
Joint sprain
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0043 affected53 at risk
EG0054 affected47 at risk
EG0062 affected41 at risk
EG0072 affected46 at risk
EG0081 affected46 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0040 affected53 at risk
EG0053 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0083 affected46 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected43 at risk
EG0022 affected44 at risk
EG0032 affected40 at risk
EG0044 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0073 affected46 at risk
EG0081 affected46 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0071 affected46 at risk
EG0082 affected46 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0030 affected40 at risk
EG0040 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0025 affected44 at risk
EG0032 affected40 at risk
EG0042 affected53 at risk
EG0057 affected47 at risk
EG0062 affected41 at risk
EG0073 affected46 at risk
EG0083 affected46 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG00014 affected46 at risk
EG0017 affected43 at risk
EG00213 affected44 at risk
EG0039 affected40 at risk
EG00412 affected53 at risk
EG00511 affected47 at risk
EG00610 affected41 at risk
EG00712 affected46 at risk
EG0088 affected46 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0032 affected40 at risk
EG0042 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0006 affected46 at risk
EG0018 affected43 at risk
EG00213 affected44 at risk
EG0035 affected40 at risk
EG00410 affected53 at risk
EG0058 affected47 at risk
EG00610 affected41 at risk
EG0079 affected46 at risk
EG0087 affected46 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0073 affected46 at risk
EG0080 affected46 at risk
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0013 affected43 at risk
EG0021 affected44 at risk
EG0032 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0062 affected41 at risk
EG0070 affected46 at risk
EG0081 affected46 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0025 affected44 at risk
EG0030 affected40 at risk
EG0044 affected53 at risk
EG0051 affected47 at risk
EG0062 affected41 at risk
EG0072 affected46 at risk
EG0081 affected46 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected46 at risk
EG0014 affected43 at risk
EG0024 affected44 at risk
EG0033 affected40 at risk
EG0046 affected53 at risk
EG0055 affected47 at risk
EG0065 affected41 at risk
EG0075 affected46 at risk
EG0085 affected46 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0042 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0033 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0071 affected46 at risk
EG0084 affected46 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0012 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0045 affected53 at risk
EG0055 affected47 at risk
EG0062 affected41 at risk
EG0075 affected46 at risk
EG0084 affected46 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0013 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0063 affected41 at risk
EG0072 affected46 at risk
EG0083 affected46 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected46 at risk
EG0012 affected43 at risk
EG0020 affected44 at risk
EG0032 affected40 at risk
EG0040 affected53 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0085 affected46 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0008 affected46 at risk
EG0016 affected43 at risk
EG0026 affected44 at risk
EG0037 affected40 at risk
EG00411 affected53 at risk
EG0057 affected47 at risk
EG0065 affected41 at risk
EG00713 affected46 at risk
EG0087 affected46 at risk
Shoulder pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0007 affected46 at risk
EG0016 affected43 at risk
EG0025 affected44 at risk
EG0032 affected40 at risk
EG0043 affected53 at risk
EG0056 affected47 at risk
EG0066 affected41 at risk
EG0072 affected46 at risk
EG0084 affected46 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0032 affected40 at risk
EG0040 affected53 at risk
EG0052 affected47 at risk
EG0064 affected41 at risk
EG0072 affected46 at risk
EG0082 affected46 at risk
Dizziness
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected43 at risk
EG0025 affected44 at risk
EG0033 affected40 at risk
EG0046 affected53 at risk
EG0054 affected47 at risk
EG0062 affected41 at risk
EG0071 affected46 at risk
EG0084 affected46 at risk
Headache
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0008 affected46 at risk
EG0011 affected43 at risk
EG0026 affected44 at risk
EG0033 affected40 at risk
EG0049 affected53 at risk
EG0056 affected47 at risk
EG0065 affected41 at risk
EG0078 affected46 at risk
EG0085 affected46 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Migraine
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0021 affected44 at risk
EG0031 affected40 at risk
EG0044 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Paraesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected43 at risk
EG0024 affected44 at risk
EG0031 affected40 at risk
EG0042 affected53 at risk
EG0051 affected47 at risk
EG0062 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Sciatica
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected43 at risk
EG0022 affected44 at risk
EG0035 affected40 at risk
EG0042 affected53 at risk
EG0052 affected47 at risk
EG0062 affected41 at risk
EG0073 affected46 at risk
EG0081 affected46 at risk
Anxiety
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0045 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0074 affected46 at risk
EG0083 affected46 at risk
Depression
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0036 affected40 at risk
EG0046 affected53 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0073 affected46 at risk
EG0083 affected46 at risk
Insomnia
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0012 affected43 at risk
EG0026 affected44 at risk
EG0034 affected40 at risk
EG0044 affected53 at risk
EG0054 affected47 at risk
EG0061 affected41 at risk
EG0072 affected46 at risk
EG0080 affected46 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0042 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0043 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Breast cyst
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0022 affected44 at risk
EG0030 affected40 at risk
EG0043 affected53 at risk
EG0051 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0012 affected43 at risk
EG0022 affected44 at risk
EG0034 affected40 at risk
EG0043 affected53 at risk
EG0053 affected47 at risk
EG0062 affected41 at risk
EG0075 affected46 at risk
EG0080 affected46 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0032 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0083 affected46 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0030 affected40 at risk
EG0042 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected46 at risk
EG0013 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0044 affected53 at risk
EG0052 affected47 at risk
EG0063 affected41 at risk
EG0073 affected46 at risk
EG0081 affected46 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0021 affected44 at risk
EG0033 affected40 at risk
EG0045 affected53 at risk
EG0052 affected47 at risk
EG0061 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0040 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0012 affected43 at risk
EG0022 affected44 at risk
EG0032 affected40 at risk
EG0043 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0071 affected46 at risk
EG0081 affected46 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0020 affected44 at risk
EG0033 affected40 at risk
EG0042 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0071 affected46 at risk
EG0080 affected46 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0051 affected47 at risk
EG0063 affected41 at risk
EG0070 affected46 at risk
EG0080 affected46 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected43 at risk
EG0022 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0052 affected47 at risk
EG0060 affected41 at risk
EG0073 affected46 at risk
EG0081 affected46 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected43 at risk
EG0022 affected44 at risk
EG0034 affected40 at risk
EG0043 affected53 at risk
EG0052 affected47 at risk
EG0063 affected41 at risk
EG0075 affected46 at risk
EG0082 affected46 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected43 at risk
EG0023 affected44 at risk
EG0030 affected40 at risk
EG0042 affected53 at risk
EG0053 affected47 at risk
EG0060 affected41 at risk
EG0070 affected46 at risk
EG0082 affected46 at risk
Hot flush
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected43 at risk
EG0023 affected44 at risk
EG0031 affected40 at risk
EG0041 affected53 at risk
EG0050 affected47 at risk
EG0060 affected41 at risk
EG0073 affected46 at risk
EG0083 affected46 at risk
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0002 affected46 at risk
EG0014 affected43 at risk
EG0028 affected44 at risk
EG0035 affected40 at risk
EG00412 affected53 at risk
EG0055 affected47 at risk
EG00610 affected41 at risk
EG0074 affected46 at risk
EG0085 affected46 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.