TriangleNCT02470585 · OUTCOME
Overall Survival (OS) in the BRCA-deficient Population
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 the time of randomization to the end of the study, up to 98 months
What was measured
OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.
Analysis population: BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation
Groups in this outcome
Placebo + Carboplatin + Paclitaxel -> Placebo
Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
Veliparib + Carboplatin + Paclitaxel -> Placebo
Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
Veliparib + Carboplatin + Paclitaxel -> Veliparib
Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
| Group | Source count |
|---|---|
| Placebo + Carboplatin + Paclitaxel -> Placebo | 92 |
| Veliparib + Carboplatin + Paclitaxel -> Placebo | 98 |
| Veliparib + Carboplatin + Paclitaxel -> Veliparib | 108 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Carboplatin + Paclitaxel -> Placebo | 89.5 | Not reported | 83.3 | NA | Could not be estimated due to the low number of events |
| Veliparib + Carboplatin + Paclitaxel -> Placebo | NA | Not reported | 69.3 | NA | Could not be estimated due to the low number of events |
| Veliparib + Carboplatin + Paclitaxel -> Veliparib | NA | Not reported | NA | NA | Could not be estimated due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 0.567
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.429
- estimate Comment
- Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above
- group Description
- Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.328
- p Value Comment
- Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.900
- statistical Method
- Log Rank
- ci Lower Limit
- 0.780
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.903
- estimate Comment
- Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
- group Description
- Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.808
- p Value Comment
- Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
- param Type
- Hazard Ratio (HR)
- param Value
- 1.218
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.567
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.429
- estimate Comment
- Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above
- group Description
- Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.328
- p Value Comment
- Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.900
- statistical Method
- Log Rank
- ci Lower Limit
- 0.780
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.903
- estimate Comment
- Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
- group Description
- Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.808
- p Value Comment
- Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
- param Type
- Hazard Ratio (HR)
- param Value
- 1.218
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events
- group Id
- OG000
- lower Limit
- 83.3
- upper Limit
- NA
- value
- 89.5
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 69.3
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the low number of events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 98
- group Id
- OG002
- value
- 108
- units
- Participants
- description
- OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- OG000
- title
- Placebo + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- OG001
- title
- Veliparib + Carboplatin + Paclitaxel -> Placebo
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
- id
- OG002
- title
- Veliparib + Carboplatin + Paclitaxel -> Veliparib
- param Type
- MEDIAN
- population Description
- BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation
- reporting Status
- POSTED
- time Frame
- From the time of randomization to the end of the study, up to 98 months
- title
- Overall Survival (OS) in the BRCA-deficient Population
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice