TriangleNCT00321620 · OUTCOME
Time to the First-And-Subsequent On-Study SRE
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Events
- Interval / dispersion
- Not reported
- Time frame
- Up to 40.5 months
What was measured
Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.
Analysis population: Full Analysis Set, composed of all randomized participants
Groups in this outcome
Zoledronic Acid
Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
Denosumab
Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
| Group | Source count |
|---|---|
| Zoledronic Acid | 951 |
| Denosumab | 950 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid | 584 | Not reported | Not reported | Not reported | Not reported |
| Denosumab | 494 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.71
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- estimate Comment
- Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0085
- param Type
- Rate ratio
- param Value
- 0.82
- statistical Comment
- P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.
- statistical Method
- Anderson-Gill model
Complete source fields
- analyses
- ci Lower Limit
- 0.71
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- estimate Comment
- Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0085
- param Type
- Rate ratio
- param Value
- 0.82
- statistical Comment
- P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.
- statistical Method
- Anderson-Gill model
- classes
- categories
- measurements
- group Id
- OG000
- value
- 584
- group Id
- OG001
- value
- 494
- denoms
- counts
- group Id
- OG000
- value
- 951
- group Id
- OG001
- value
- 950
- units
- Participants
- description
- Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.
- groups
- description
- Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
- id
- OG000
- title
- Zoledronic Acid
- description
- Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
- id
- OG001
- title
- Denosumab
- param Type
- NUMBER
- population Description
- Full Analysis Set, composed of all randomized participants
- reporting Status
- POSTED
- time Frame
- Up to 40.5 months
- title
- Time to the First-And-Subsequent On-Study SRE
- type
- SECONDARY
- unit Of Measure
- Events
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice