TriangleNCT01568866 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
What was measured
Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method.
Analysis population: Intent-to-treat population
Groups in this outcome
Bortezomib + DEX
Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Carfilzomib + DEX
Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
| Group | Source count |
|---|---|
| Bortezomib + DEX | 465 |
| Carfilzomib + DEX | 464 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib + DEX | 40.0 | Not reported | 32.6 | 42.3 | Not reported |
| Carfilzomib + DEX | 47.6 | Not reported | 42.5 | NA | Could not be estimated due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 0.648
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.964
- estimate Comment
- The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.
- group Description
- The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0100
- p Value Comment
- The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.791
- statistical Comment
- Log rank test stratified by the randomization stratification factors.
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.648
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.964
- estimate Comment
- The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.
- group Description
- The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0100
- p Value Comment
- The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.791
- statistical Comment
- Log rank test stratified by the randomization stratification factors.
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.6
- upper Limit
- 42.3
- value
- 40.0
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 42.5
- upper Limit
- NA
- value
- 47.6
- denoms
- counts
- group Id
- OG000
- value
- 465
- group Id
- OG001
- value
- 464
- units
- Participants
- description
- Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
- id
- OG000
- title
- Bortezomib + DEX
- description
- Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
- id
- OG001
- title
- Carfilzomib + DEX
- param Type
- MEDIAN
- population Description
- Intent-to-treat population
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice