Trial Outcomes & Findings for Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer (NCT NCT00286091)
NCT ID: NCT00286091
Last Updated: 2018-10-17
Results Overview
The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1435 participants
Primary outcome timeframe
From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.
Results posted on
2018-10-17
Participant Flow
Eligible subjects were men ≥ 18 years old with histologically-confirmed, castrate-resistant prostate cancer who were chemically or surgically castrated. The first patient was enrolled into the study on 03 February 2006 and the last patient was enrolled on 23 July 2008.
Participants were randomized to denosumab or placebo in the double-blind treatment phase. All participants undergoing scheduled assessments were offered open-label denosumab for up to 3 years in the open-label extension phase. Three enrolled patients were excluded from all datasets per ethics committee's instructions due to eligibility violations.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|
|
Double-blind Treatment Phase
STARTED
|
716
|
716
|
|
Double-blind Treatment Phase
Received Treatment
|
709
|
716
|
|
Double-blind Treatment Phase
On Study at Primary Data Analysis Cutoff
|
164
|
174
|
|
Double-blind Treatment Phase
COMPLETED
|
132
|
123
|
|
Double-blind Treatment Phase
NOT COMPLETED
|
584
|
593
|
|
Open-label Treatment Phase
STARTED
|
110
|
104
|
|
Open-label Treatment Phase
Received Treatment
|
109
|
101
|
|
Open-label Treatment Phase
COMPLETED
|
33
|
33
|
|
Open-label Treatment Phase
NOT COMPLETED
|
77
|
71
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|
|
Double-blind Treatment Phase
Withdrawal by Subject
|
103
|
113
|
|
Double-blind Treatment Phase
Protocol-Specified Criteria
|
307
|
269
|
|
Double-blind Treatment Phase
Death
|
58
|
65
|
|
Double-blind Treatment Phase
Adverse Event
|
28
|
40
|
|
Double-blind Treatment Phase
Disease Progression
|
22
|
35
|
|
Double-blind Treatment Phase
Other
|
25
|
33
|
|
Double-blind Treatment Phase
Administrative Decision
|
20
|
21
|
|
Double-blind Treatment Phase
Noncompliance
|
8
|
8
|
|
Double-blind Treatment Phase
Lost to Follow-up
|
11
|
4
|
|
Double-blind Treatment Phase
Protocol Deviation
|
1
|
3
|
|
Double-blind Treatment Phase
Ineligibility Determined
|
1
|
2
|
|
Open-label Treatment Phase
Physician Decision
|
24
|
21
|
|
Open-label Treatment Phase
Adverse Event
|
5
|
16
|
|
Open-label Treatment Phase
Other
|
11
|
11
|
|
Open-label Treatment Phase
Withdrawal by Subject
|
14
|
10
|
|
Open-label Treatment Phase
Death
|
10
|
7
|
|
Open-label Treatment Phase
Disease Progression
|
9
|
3
|
|
Open-label Treatment Phase
Noncompliance
|
3
|
1
|
|
Open-label Treatment Phase
Lost to Follow-up
|
0
|
1
|
|
Open-label Treatment Phase
Protocol-specified Criteria
|
1
|
0
|
|
Open-label Treatment Phase
Missing End of Study Information
|
0
|
1
|
Baseline Characteristics
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=716 Participants
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
n=716 Participants
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Total
n=1432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
73.2 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
73.2 years
STANDARD_DEVIATION 8.6 • 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
|
716 Participants
n=5 Participants
|
716 Participants
n=7 Participants
|
1432 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
604 participants
n=5 Participants
|
606 participants
n=7 Participants
|
1210 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
35 participants
n=5 Participants
|
41 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
37 participants
n=5 Participants
|
32 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Pperformance Status
Grade 0
|
514 participants
n=5 Participants
|
505 participants
n=7 Participants
|
1019 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Pperformance Status
Grade 1
|
199 participants
n=5 Participants
|
210 participants
n=7 Participants
|
409 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Pperformance Status
Grade 2
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Pperformance Status
Grade 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Pperformance Status
Grade 4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Prostate-Specific Antigen (PSA) Doubling Time
≤ 10 months
|
580 participants
n=5 Participants
|
574 participants
n=7 Participants
|
1154 participants
n=5 Participants
|
|
Prostate-Specific Antigen (PSA) Doubling Time
> 10 months
|
136 participants
n=5 Participants
|
142 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Prostate-Specific Antigen (PSA) ≥ 8.0 ng/mL
Yes
|
471 participants
n=5 Participants
|
473 participants
n=7 Participants
|
944 participants
n=5 Participants
|
|
Prostate-Specific Antigen (PSA) ≥ 8.0 ng/mL
No
|
245 participants
n=5 Participants
|
243 participants
n=7 Participants
|
488 participants
n=5 Participants
|
|
Prior Chemotherapy Regimens
Yes
|
54 participants
n=5 Participants
|
63 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Prior Chemotherapy Regimens
No
|
662 participants
n=5 Participants
|
653 participants
n=7 Participants
|
1315 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.Population: Full analysis set (all randomized participants)
The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Placebo
n=716 Participants
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
n=716 Participants
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|
|
Bone Metastasis-free Survival
|
768.0 days
Interval 675.0 to 897.0
|
897.00 days
Interval 773.0 to 1014.0
|
SECONDARY outcome
Timeframe: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.Population: Full analysis set
Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Placebo
n=716 Participants
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
n=716 Participants
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|
|
Time to First Bone Metastasis
|
897.0 days
Interval 683.0 to 1009.0
|
1010.0 days
Interval 897.0 to 1156.0
|
SECONDARY outcome
Timeframe: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.Population: Full analysis set
Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.
Outcome measures
| Measure |
Placebo
n=716 Participants
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
Denosumab
n=716 Participants
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|
|
Overall Survival
|
1365.0 days
Interval 1220.0 to
Could not be estimated due to the low number of events at the time of data cut-off
|
1335.0 days
Interval 1221.0 to
Could not be estimated due to the low number of events at the time of data cut-off
|
Adverse Events
DB: Placebo
Serious events: 332 serious events
Other events: 585 other events
Deaths: 0 deaths
DB: Denosumab 120 mg Q4W
Serious events: 341 serious events
Other events: 599 other events
Deaths: 0 deaths
OLE: Placebo/ Denosumab 120 mg Q4W
Serious events: 39 serious events
Other events: 80 other events
Deaths: 0 deaths
OLE: Denosumab/ Denosumab 120 mg Q4W
Serious events: 36 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB: Placebo
n=705 participants at risk
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
|
DB: Denosumab 120 mg Q4W
n=720 participants at risk
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
|
OLE: Placebo/ Denosumab 120 mg Q4W
n=109 participants at risk
Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
|
OLE: Denosumab/ Denosumab 120 mg Q4W
n=101 participants at risk
Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
12/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
25/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
12/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial tachycardia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.99%
7/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac valve disease
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiogenic shock
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
10/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
12/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Sinus bradycardia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Syringomyelia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Glaucoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
6/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ascites
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium decreased
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Faecaloma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haematemesis
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haematochezia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Melaena
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
1.4%
10/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
9/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Death
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Device battery issue
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Device malfunction
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Device occlusion
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
General physical health deterioration
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Generalised oedema
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Hernia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Impaired healing
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Local swelling
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multi-organ failure
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.71%
5/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
10/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden cardiac death
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden death
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholestasis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Jaundice
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Anaphylactic reaction
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess of salivary gland
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cardiac infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Dental fistula
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Empyema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endocarditis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enterococcal infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Epiglottitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gangrene
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastrointestinal infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Human ehrlichiosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lobar pneumonia
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Localised infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Neutropenic infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral candidiasis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Orchitis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Penile infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perineal abscess
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perineal infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
2.3%
16/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
13/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
1.1%
8/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
15/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
15/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
8/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Retinal injury
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspiration bronchial
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood urine present
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Haemoglobin decreased
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Heart rate increased
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Ultrasound liver abnormal
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
9/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
7/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
7/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
9/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exostosis of jaw
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
7/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
12/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
7/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.71%
5/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
10/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to larynx
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.85%
6/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to small intestine
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.0%
21/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
15/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.85%
6/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebellar infarction
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
10/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
8/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Coma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dementia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.56%
4/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Encephalopathy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Epilepsy
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Gait apraxia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypertonia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Loss of consciousness
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinson's disease
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Presyncope
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Somnolence
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
8/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Completed suicide
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Confusional state
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Disorientation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Anuria
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus bladder
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Calculus urinary
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Dysuria
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
7/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematinuria
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
3.5%
25/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
37/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.6%
11/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.1%
15/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Incontinence
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Micturition disorder
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Oliguria
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Pollakiuria
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.83%
6/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
9/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
16/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
16/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.7%
12/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
4.7%
33/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
56/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
6/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.7%
12/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatic perforation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.99%
7/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.4%
10/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
5/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
8/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
9/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Physical disability
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cancer surgery
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cardioversion
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cataract operation
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cystostomy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Debridement
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Finger amputation
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Heart valve operation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Orchidectomy
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Skin graft
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Stent placement
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arterial thrombosis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
6/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
8/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertensive crisis
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.57%
4/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.69%
5/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Intermittent claudication
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.42%
3/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Orthostatic hypotension
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral ischaemia
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Shock
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.28%
2/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.43%
3/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vascular occlusion
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.14%
1/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis
|
0.28%
2/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis limb
|
0.14%
1/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
DB: Placebo
n=705 participants at risk
Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
|
DB: Denosumab 120 mg Q4W
n=720 participants at risk
Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
|
OLE: Placebo/ Denosumab 120 mg Q4W
n=109 participants at risk
Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
|
OLE: Denosumab/ Denosumab 120 mg Q4W
n=101 participants at risk
Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
74/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
80/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.0%
12/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
10/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
47/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
59/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
7/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
124/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.8%
128/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.9%
13/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.9%
15/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
10/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
16/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.5%
102/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.3%
110/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
8/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
10/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
13.5%
95/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.6%
98/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.9%
14/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
2.3%
16/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.4%
32/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
55/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
59/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
10/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
12.9%
91/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.8%
92/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
8/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.9%
11/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
11.6%
82/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.6%
98/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.6%
5/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
8/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
12.5%
88/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.1%
94/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.6%
5/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.9%
11/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
4.5%
32/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
40/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
5.4%
38/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.8%
49/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
7/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
72/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.4%
68/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
7/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
23/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
46/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
8/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
8/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
13.6%
96/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.0%
108/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.8%
15/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.9%
14/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
6.0%
42/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
36/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
6.0%
42/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
39/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
61/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
63/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
7/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
116/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.1%
123/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
11/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.9%
9/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.6%
159/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
23.1%
166/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.0%
24/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
8/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
28/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
46/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
6/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.4%
59/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
58/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
8/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
24/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.3%
24/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
6/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
17/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.9%
12/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
88/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.0%
101/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.0%
12/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
10/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.99%
7/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
25/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
8.2%
58/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
56/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
7.9%
56/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
63/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
7/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
7.7%
54/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.3%
67/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
6.2%
44/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
46/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Dysuria
|
9.4%
66/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
73/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.6%
5/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
7/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
12.8%
90/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.1%
87/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.6%
17/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.9%
11/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nocturia
|
3.7%
26/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
39/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
3/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
50/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
61/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.3%
30/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.2%
30/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
8/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
8.9%
63/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
73/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
6/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
7/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
60/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.6%
55/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.5%
6/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.1%
57/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.5%
61/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.7%
4/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
32/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
37/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
2/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hot flush
|
4.5%
32/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.7%
41/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.92%
1/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.99%
1/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
7.0%
49/705 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
59/720 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.6%
5/109 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
6/101 • Median investigational product exposure was 18.4 and 19.3 months in the placebo and denosumab groups respectively during the double blind phase and 23.7 and 24.9 months during the open-label treatment phase.
Four participants who were randomized to placebo received ≥ 1 dose of denosumab; therefore, these participants were included within the denosumab group for the safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
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