TriangleNCT01345019 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
What was measured
Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.
Analysis population: All randomized participants
Groups in this outcome
Zoledronic Acid
Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
Denosumab
Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
| Group | Source count |
|---|---|
| Zoledronic Acid | 859 |
| Denosumab | 859 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid | NA | Not reported | NA | NA | Not estimable, the median survival and 95% CI were not reached |
| Denosumab | 1507.0 | Not reported | NA | NA | The 95% CI was not estimable as there were no participants in the risk set who survived at the median time |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.16
- estimate Comment
- A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.
- group Description
- The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Cox proportional hazards model
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.16
- estimate Comment
- A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.
- group Description
- The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Cox proportional hazards model
- classes
- categories
- measurements
- comment
- Not estimable, the median survival and 95% CI were not reached
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The 95% CI was not estimable as there were no participants in the risk set who survived at the median time
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 1507.0
- denoms
- counts
- group Id
- OG000
- value
- 859
- group Id
- OG001
- value
- 859
- units
- Participants
- description
- Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.
- id
- OG000
- title
- Zoledronic Acid
- description
- Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
- id
- OG001
- title
- Denosumab
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice