Trial Outcomes & Findings for AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer (NCT NCT00089674)

NCT ID: NCT00089674

Last Updated: 2018-10-17

Results Overview

Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1468 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2018-10-17

Participant Flow

First Subject Enrolled: 15-Apr-2004 Last Subject Enrolled: 29-Apr-2005

Participant milestones

Measure	Placebo Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Overall Study STARTED	734	734
Overall Study Received Study Drug	730	726
Overall Study COMPLETED	445	467
Overall Study NOT COMPLETED	289	267

Reasons for withdrawal

Measure	Placebo Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Overall Study Physician Decision	4	2
Overall Study Adverse Event	23	29
Overall Study Withdrawal by Subject	143	127
Overall Study Death	43	43
Overall Study Disease progression	21	23
Overall Study Ineligibility determined	8	10
Overall Study Lost to Follow-up	21	17
Overall Study Noncompliance	7	3
Overall Study Other	5	9
Overall Study Requirement for alternative therapy	14	4

Baseline Characteristics

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

Baseline characteristics by cohort

Measure	Placebo n=734 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=734 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years	Total n=1468 Participants Total of all reporting groups
Age, Continuous	75.5 Years STANDARD_DEVIATION 7.1 • n=5 Participants	75.3 Years STANDARD_DEVIATION 7 • n=7 Participants	75.4 Years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	734 Participants n=5 Participants	734 Participants n=7 Participants	1468 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	609 Participants n=5 Participants	615 Participants n=7 Participants	1224 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	81 Participants n=5 Participants	77 Participants n=7 Participants	158 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.

Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=716 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=714 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	-1 Percent Change from Baseline Interval -1.4 to -0.7	5.6 Percent Change from Baseline Interval 5.3 to 5.9

SECONDARY outcome

Timeframe: 24 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=706 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=701 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24	-1.5 Percent Change from Baseline Interval -1.8 to -1.1	2.4 Percent Change from Baseline Interval 2.1 to 2.8

SECONDARY outcome

Timeframe: 24 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.

Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=706 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=701 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	-2 Percent Change from Baseline Interval -2.3 to -1.8	2.7 Percent Change from Baseline Interval 2.5 to 3.0

SECONDARY outcome

Timeframe: 36 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=716 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=714 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36	-1.2 Percent Change from Baseline Interval -1.5 to -0.8	6.8 Percent Change from Baseline Interval 6.4 to 7.1

SECONDARY outcome

Timeframe: 36 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.

Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=706 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=701 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36	-1.8 Percent Change from Baseline Interval -2.2 to -1.5	3 Percent Change from Baseline Interval 2.7 to 3.4

SECONDARY outcome

Timeframe: 36 months

Population: Randomized subjects who had a nonmissing baseline and \>= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.

Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.

Outcome measures

Measure	Placebo n=706 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=701 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36	-2.6 Percent Change from Baseline Interval -2.8 to -2.3	3.2 Percent Change from Baseline Interval 2.9 to 3.4

SECONDARY outcome

Timeframe: 36 months

Population: Full analysis set

Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

Outcome measures

Measure	Placebo n=734 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=734 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Number of Participants With Any Fracture Through Month 36	53 Participants	38 Participants

SECONDARY outcome

Timeframe: 36 months

Population: All randomized subjects who have a baseline and \>= 1 postbaseline evaluation of vertebral fracture at or before 3 years.

New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.

Outcome measures

Measure	Placebo n=673 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=679 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Number of Participants With a New Vertebral Fracture Through Month 36	26 Participants	10 Participants

SECONDARY outcome

Timeframe: 36 months

Population: Full analysis set

A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.

Outcome measures

Measure	Placebo n=734 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=734 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Time to First Clinical Fracture Through Month 36	5.2 Percentage of participants	4.7 Percentage of participants

SECONDARY outcome

Timeframe: 24 months

Population: Full analysis set

Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.

Outcome measures

Measure	Placebo n=734 Participants Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=734 Participants Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Number of Participants With Any Fracture Through Month 24	45 Participants	32 Participants

Adverse Events

Placebo

Serious events: 222 serious events

Other events: 364 other events

Deaths: 0 deaths

Denosumab 60 mg Q6M

Serious events: 253 serious events

Other events: 390 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=725 participants at risk Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=731 participants at risk Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Vascular disorders Hypotension	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Hypovolaemic shock	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Iliac artery occlusion	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Arterial thrombosis limb	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Cardiovascular insufficiency	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Circulatory collapse	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Deep vein thrombosis	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Femoral artery aneurysm	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Haematoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Haemorrhage	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Hypertension	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Hypertensive crisis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Ischaemia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Lymphoedema	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Orthostatic hypotension	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.82% 6/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Skin and subcutaneous tissue disorders Skin necrosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Cardiac pacemaker replacement	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Cholecystectomy	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Hernia repair	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Hip arthroplasty	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Kidney ablation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Knee arthroplasty	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Surgical and medical procedures Spinal operation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Aortic aneurysm	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Aortic dissection	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Aortic stenosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Arterial occlusive disease	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Blood and lymphatic system disorders Anaemia	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Blood and lymphatic system disorders Leukopenia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Blood and lymphatic system disorders Thrombocytopenia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Acute coronary syndrome	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Acute myocardial infarction	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Angina pectoris	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Angina unstable	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Aortic valve disease	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Aortic valve incompetence	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Aortic valve stenosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Arrhythmia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Arteriosclerosis coronary artery	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Atrial fibrillation	1.1% 8/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.5% 11/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Atrial flutter	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Atrial tachycardia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Atrioventricular block	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Atrioventricular block complete	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Bradycardia	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiac arrest	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiac disorder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiac failure	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiac failure congestive	1.4% 10/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.82% 6/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiac flutter	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiogenic shock	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiomyopathy	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Cardiovascular disorder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Coronary artery disease	1.5% 11/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.2% 9/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Coronary artery stenosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Coronary artery thrombosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Mitral valve incompetence	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Myocardial fibrosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Myocardial infarction	2.5% 18/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.9% 14/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Myocardial ischaemia	0.83% 6/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Sick sinus syndrome	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Sinus arrhythmia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Tachycardia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Trifascicular block	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Ventricular fibrillation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Cardiac disorders Ventricular tachycardia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Congenital, familial and genetic disorders Atrial septal defect	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Congenital, familial and genetic disorders Coarctation of the aorta	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Ear and labyrinth disorders Vertigo	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Endocrine disorders Hyperthyroidism	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Endocrine disorders Hypothyroidism	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Eye disorders Cataract	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Eye disorders Glaucoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Eye disorders Retinal detachment	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Eye disorders Retinal vascular thrombosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Abdominal pain	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Abdominal pain upper	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Colitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Colitis ischaemic	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Colonic polyp	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Constipation	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Diarrhoea	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Diverticulum	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Dyspepsia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Dysphagia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Enterovesical fistula	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Faecal incontinence	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Gastritis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Haematochezia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Haemorrhoids	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Hiatus hernia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Inguinal hernia	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Intestinal infarction	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Intestinal perforation	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Leukoplakia oral	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Lumbar hernia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Nausea	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Pancreatitis	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Peritoneal disorder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Rectal haemorrhage	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Small intestinal obstruction	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Stomach discomfort	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Subileus	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Umbilical hernia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Umbilical hernia, obstructive	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Vomiting	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Asthenia	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Chest discomfort	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Chest pain	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Condition aggravated	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Death	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Gait disturbance	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders General physical health deterioration	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Generalised oedema	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Hypothermia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Impaired healing	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Malaise	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Non-cardiac chest pain	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Oedema peripheral	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Pelvic mass	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Pyrexia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Sudden death	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Biliary dyskinesia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Cholecystitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Cholelithiasis	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Hepatic failure	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Hepatitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Hepatobiliary disorders Jaundice	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Immune system disorders Drug hypersensitivity	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Abdominal abscess	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Appendicitis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Arthritis bacterial	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Arthritis infective	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Bronchitis	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Bronchopneumonia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Bursitis infective staphylococcal	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Cellulitis	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Clostridium difficile colitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Cystitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Diverticulitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Endocarditis bacterial	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Erysipelas	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Gangrene	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Gastroenteritis	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Gastroenteritis salmonella	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Gastroenteritis viral	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Gastrointestinal gangrene	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Infected skin ulcer	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Influenza	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Labyrinthitis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Lobar pneumonia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Localised infection	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Osteomyelitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Paronychia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pneumococcal sepsis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pneumonia	1.5% 11/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.5% 11/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pneumonia staphylococcal	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Postoperative abscess	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Postoperative wound infection	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Prostate infection	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pseudomembranous colitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pseudomonas infection	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Pyothorax	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Sepsis	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Septic shock	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Urinary tract infection	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Urosepsis	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Viral infection	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Clavicle fracture	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Concussion	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Device failure	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Failure of implant	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Fall	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Femoral neck fracture	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Femur fracture	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Fibula fracture	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Humerus fracture	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Injury	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Nerve root injury cervical	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Pacemaker complication	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Periorbital haematoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Post procedural complication	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Procedural hypertension	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Radius fracture	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Rib fracture	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Road traffic accident	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Stenosis of vesicourethral anastomosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Subdural haemorrhage	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Tibia fracture	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Ulna fracture	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Wound dehiscence	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Dehydration	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.82% 6/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Diabetic foot	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Hyperglycaemia	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Arthritis	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Back pain	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Bone pain	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Flank pain	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Joint lock	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Myalgia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.82% 6/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant glioma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal cavity	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	1.4% 10/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncocytoma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Altered state of consciousness	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Ataxia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Brain injury	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Carotid artery occlusion	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Carotid artery stenosis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebral haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebral infarction	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebral ischaemia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebrovascular accident	1.7% 12/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.4% 10/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebrovascular disorder	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Cerebrovascular spasm	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Convulsion	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Dementia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Depressed level of consciousness	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Dizziness	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Encephalopathy	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Facial paresis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Haemorrhage intracranial	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Haemorrhagic stroke	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Headache	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Hemiparesis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Hypoaesthesia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Hypoxic encephalopathy	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Ischaemic stroke	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Loss of consciousness	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Parkinson's disease	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Parkinsonism	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Presyncope	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Sciatica	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Senile dementia	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Syncope	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.1% 8/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Syncope vasovagal	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Thalamus haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Transient ischaemic attack	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.2% 9/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Alcoholism	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Confusional state	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Delirium	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Depression	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Hallucination	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Major depression	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Psychiatric disorders Suicidal ideation	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Anuria	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Bladder obstruction	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Calculus bladder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Calculus ureteric	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Contracted bladder	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Dysuria	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Haematuria	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Hydronephrosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Polyuria	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Renal colic	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Renal cyst	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Renal failure	0.55% 4/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.55% 4/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Renal failure acute	0.69% 5/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.41% 3/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Renal failure chronic	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Ureteric obstruction	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Ureteric perforation	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Urethral obstruction	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Urinary retention	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.82% 6/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Urinary tract disorder	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Reproductive system and breast disorders Prostatic obstruction	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.68% 5/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.41% 3/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	1.1% 8/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Peripheral artery aneurysm	0.28% 2/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Peripheral vascular disorder	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Thrombophlebitis	0.14% 1/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.00% 0/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Thrombosis	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.27% 2/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Venous occlusion	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Venous thrombosis limb	0.00% 0/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	0.14% 1/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.

Other adverse events

Measure	Placebo n=725 participants at risk Placebo administered subcutaneous every 6 months for 3 years	Denosumab 60 mg Q6M n=731 participants at risk Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Gastrointestinal disorders Constipation	10.2% 74/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	10.0% 73/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Gastrointestinal disorders Diarrhoea	5.4% 39/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	5.3% 39/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Fatigue	6.2% 45/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	6.0% 44/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
General disorders Oedema peripheral	6.5% 47/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	7.1% 52/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Nasopharyngitis	6.2% 45/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	6.4% 47/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Infections and infestations Urinary tract infection	4.1% 30/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	5.1% 37/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Arthralgia	10.9% 79/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	12.4% 91/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Back pain	10.1% 73/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	10.8% 79/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.6% 26/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	5.5% 40/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 51/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	9.0% 66/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Nervous system disorders Dizziness	4.3% 31/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	5.6% 41/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Hot flush	4.4% 32/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	5.2% 38/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Vascular disorders Hypertension	6.5% 47/725 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.	7.4% 54/731 • 36 months Five participants randomized to placebo received 1 dose of denosumab in error and are included in the denosumab group for safety analysis. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER