TriangleNCT00321464 · OUTCOME
Time to First and Subsequent On-Study Skeletal-Related Event
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 34 months
What was measured
Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, 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 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 subcutaneous denosumab placebo once every 4 weeks
Denosumab
Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
| Group | Source count |
|---|---|
| Zoledronic Acid | 1020 |
| Denosumab | 1026 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zoledronic Acid | 608 | Not reported | Not reported | Not reported | Not reported |
| Denosumab | 474 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.66
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- estimate Comment
- Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- p Value Comment
- P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure
- param Type
- Rate ratio
- param Value
- 0.77
- statistical Method
- Anderson-Gill model
Complete source fields
- analyses
- ci Lower Limit
- 0.66
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- estimate Comment
- Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.001
- p Value Comment
- P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure
- param Type
- Rate ratio
- param Value
- 0.77
- statistical Method
- Anderson-Gill model
- classes
- categories
- measurements
- group Id
- OG000
- value
- 608
- group Id
- OG001
- value
- 474
- denoms
- counts
- group Id
- OG000
- value
- 1020
- group Id
- OG001
- value
- 1026
- units
- Participants
- description
- Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, 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 number of events.
- groups
- description
- Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
- id
- OG000
- title
- Zoledronic Acid
- description
- Denomsumab 120 mg subcutaneously with 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 34 months
- title
- Time to First and Subsequent On-Study Skeletal-Related Event
- type
- SECONDARY
- unit Of Measure
- Events
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice