TriangleNCT01077154 · OUTCOME
Distant Recurrence-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the primary analysis data cut-off date of 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
What was measured
Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date. Distant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence. Since the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported.
Analysis population: All randomized participants
Groups in this outcome
Placebo
Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
Denosumab
Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
| Group | Source count |
|---|---|
| Placebo | 2253 |
| Denosumab | 2256 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 18.0 | Not reported | 16.4 | 19.6 | Not reported |
| Denosumab | 18.7 | Not reported | 17.1 | 20.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.92
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.21
- estimate Comment
- Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- statistical Comment
- Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.92
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.21
- estimate Comment
- Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.41
- param Type
- Hazard Ratio (HR)
- param Value
- 1.06
- statistical Comment
- Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.4
- upper Limit
- 19.6
- value
- 18.0
- group Id
- OG001
- lower Limit
- 17.1
- upper Limit
- 20.3
- value
- 18.7
- denoms
- counts
- group Id
- OG000
- value
- 2253
- group Id
- OG001
- value
- 2256
- units
- Participants
- description
- Distant recurrence-free survival (DRFS) was defined as the time interval from the randomization date to the date of first observation of distant disease recurrence or death from any cause, whichever came first. Participants last known to be alive, who had not experienced distant disease recurrence, were censored at their last assessment date, or at the primary analysis data cut-off date, whichever was first. Participants who had first distant recurrence before randomization were censored at their randomization date. Distant disease recurrence includes confirmed bone metastasis and extraosseous disease other than local-regional disease recurrence. Development of non-breast cancer new primary malignancy was not considered as distant disease recurrence. Since the median time to DRFS could not be estimated due to the low number of events, the percentage of participants with an event (i.e., distant recurrence or death) is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
- id
- OG000
- title
- Placebo
- description
- Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
- 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 31 August 2017; median (minimum, maximum) time on study was 67.2 (0.0, 85.9) and 67.0 (0.0, 86.6) months in each treatment group respectively.
- title
- Distant Recurrence-free Survival
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice