Trial Outcomes & Findings for Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer (NCT NCT00838201)

NCT ID: NCT00838201

Last Updated: 2018-10-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 384 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2018-10-18

Participant Flow

First subject enrollment date: 18 February 2009; Last subject enrollment date: 11 May 2010

Only recruited those who were participating in the safety follow-up of 20040138 study at the time, were willing to receive Denosumab, and met the inclusion/exclusion criteria. The first portion of the arm label indicates subjects' treatment groups (Placebo or Denosumab) in the parent study 20040138

Participant milestones

Measure	Placebo/Denosumab 60 mg SC Q6M Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/Denosumab 60 mg SC Q6M Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Overall Study STARTED	186	198
Overall Study COMPLETED	144	145
Overall Study NOT COMPLETED	42	53

Reasons for withdrawal

Measure	Placebo/Denosumab 60 mg SC Q6M Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/Denosumab 60 mg SC Q6M Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Overall Study Investigator decision, or other reasons	2	3
Overall Study Noncompliance	0	1
Overall Study Administrative decision	1	2
Overall Study Disease progression	3	3
Overall Study Consent withdrawn	16	19
Overall Study Lost to Follow-up	4	3
Overall Study Adverse Event	5	9
Overall Study Death	11	13

Baseline Characteristics

Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

Baseline characteristics by cohort

Measure	Placebo/Denosumab 60 mg SC Q6M n=186 Participants Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/Denosumab 60 mg SC Q6M n=198 Participants Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Total n=384 Participants Total of all reporting groups
Age, Continuous	73 Years STANDARD_DEVIATION 7.1 • n=5 Participants	74.1 Years STANDARD_DEVIATION 6.6 • n=7 Participants	73.6 Years STANDARD_DEVIATION 6.9 • 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	186 Participants n=5 Participants	198 Participants n=7 Participants	384 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	153 Participants n=5 Participants	173 Participants n=7 Participants	326 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Full Analysis Set

Outcome measures

Measure	Placebo/Denosumab 60 mg SC Q6M n=186 Participants Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/Denosumab 60 mg SC Q6M n=198 Participants Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Overall Survival Through Month 24	174 Participants	184 Participants

Adverse Events

Placebo/ Denosumab 60 mg Q6M

Serious events: 45 serious events

Other events: 47 other events

Deaths: 0 deaths

Denosumab/ Denosumab 60 mg Q6M

Serious events: 51 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo/ Denosumab 60 mg Q6M n=185 participants at risk Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/ Denosumab 60 mg Q6M n=199 participants at risk Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Blood and lymphatic system disorders Anaemia	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Blood and lymphatic system disorders Febrile neutropenia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Blood and lymphatic system disorders Pancytopenia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Acute coronary syndrome	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Acute myocardial infarction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Angina pectoris	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Angina unstable	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Atrioventricular block complete	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Bradycardia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Cardiac arrest	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Cardiac failure	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Cardiac failure congestive	2.7% 5/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Cardiac ventricular disorder	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Coronary artery disease	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Coronary artery stenosis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Extrasystoles	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Myocardial infarction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Cardiac disorders Sick sinus syndrome	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Congenital, familial and genetic disorders Thyroglossal cyst	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Eye disorders Cataract	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Eye disorders Glaucoma	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Abdominal pain	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Gastritis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Inguinal hernia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Intestinal perforation	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Large intestinal ulcer	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Oesophagitis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Subileus	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Umbilical hernia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Asthenia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Death	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Implant site haematoma	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Non-cardiac chest pain	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Oedema peripheral	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
General disorders Pyrexia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Hepatobiliary disorders Jaundice	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Arthritis bacterial	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Bronchitis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Cellulitis	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Clostridial infection	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Clostridium difficile colitis	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Device related infection	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Gastroenteritis	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Pneumonia	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Pneumonia bacterial	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Pneumonia pneumococcal	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Subcutaneous abscess	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Urinary tract infection	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Urosepsis	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Wound infection	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Femur fracture	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Laceration	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Postoperative wound complication	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Rib fracture	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Injury, poisoning and procedural complications Tibia fracture	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Investigations Liver function test abnormal	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Investigations Oxygen saturation abnormal	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Metabolism and nutrition disorders Dehydration	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Arthropathy	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage I	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.6% 3/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Basal ganglia infarction	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Cerebral infarction	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Cerebral ischaemia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Cerebrovascular accident	1.6% 3/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Convulsion	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Dementia	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Petit mal epilepsy	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Presyncope	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Syncope	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Nervous system disorders Transient ischaemic attack	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Psychiatric disorders Confusional state	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Psychiatric disorders Delirium	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Bladder obstruction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Haematuria	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.5% 3/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Renal failure	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Renal failure acute	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	1.0% 2/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Ureteric obstruction	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Urinary incontinence	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Urinary retention	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Renal and urinary disorders Urinary tract obstruction	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Reproductive system and breast disorders Prostatomegaly	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.1% 2/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 3/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Skin and subcutaneous tissue disorders Nail discolouration	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Aortic aneurysm	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Aortic dissection	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Aortic stenosis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Arterial stenosis	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Deep vein thrombosis	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Hypotension	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Orthostatic hypotension	0.00% 0/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.50% 1/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Vascular disorders Peripheral ischaemia	0.54% 1/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	0.00% 0/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.

Other adverse events

Measure	Placebo/ Denosumab 60 mg Q6M n=185 participants at risk Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study	Denosumab/ Denosumab 60 mg Q6M n=199 participants at risk Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 12/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	5.0% 10/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Back pain	4.3% 8/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	5.5% 11/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Constipation	8.6% 16/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	6.5% 13/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Gastrointestinal disorders Nausea	4.3% 8/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	5.5% 11/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Infections and infestations Urinary tract infection	3.2% 6/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	6.0% 12/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 11/185 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab arm.	4.5% 9/199 • about 38 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to the placebo arm of the parent study received at least one dose of denosumab in the parent study and therefore was summarized in denosumab/denosumab 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 after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER