TriangleNCT01345019 · OUTCOME
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events/patient
- Interval / dispersion
- Not reported
- 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
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE. A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported.
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 | 0.66 | Not reported | Not reported | Not reported | Not reported |
| Denosumab | 0.66 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.15
- estimate Comment
- A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.84
- param Type
- Rate ratio
- param Value
- 1.01
- statistical Comment
- Based on an Andersen-Gill model stratified by the randomization stratification factors.
- statistical Method
- Andersen-Gill model
Complete source fields
- analyses
- ci Lower Limit
- 0.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.15
- estimate Comment
- A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.84
- param Type
- Rate ratio
- param Value
- 1.01
- statistical Comment
- Based on an Andersen-Gill model stratified by the randomization stratification factors.
- statistical Method
- Andersen-Gill model
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.66
- group Id
- OG001
- value
- 0.66
- denoms
- counts
- group Id
- OG000
- value
- 859
- group Id
- OG001
- value
- 859
- units
- Participants
- description
- A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE. A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported.
- 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
- NUMBER
- 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
- Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
- type
- SECONDARY
- unit Of Measure
- events/patient
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Preserved source evidence · Not medical advice