TriangleNCT01345019 · OUTCOME
Time to First On-study Skeletal Related Event
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
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. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came 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 | 730.0 | Not reported | 504.0 | 1014.0 | Not reported |
| Denosumab | 695.0 | Not reported | 448.0 | NA | Could not be estimated due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.14
- estimate Comment
- A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Comment
- Based on a Cox proportional hazards model stratified by the randomization stratification factors.
- statistical Method
- Cox proportional hazards model
Complete source fields
- analyses
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.14
- estimate Comment
- A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.
- non Inferiority Type
- NON_INFERIORITY
- p Value
- 0.010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Comment
- Based on a Cox proportional hazards model stratified by the randomization stratification factors.
- statistical Method
- Cox proportional hazards model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 504.0
- upper Limit
- 1014.0
- value
- 730.0
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 448.0
- upper Limit
- NA
- value
- 695.0
- 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. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came 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
- Time to First On-study Skeletal Related Event
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice