TriangleNCT02908672 · OUTCOME
Percentage of Participants Who Have Survived at 2 Years
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
- 2 years
What was measured
Percentage of participants with OS which was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate 2-year landmark survival rate. The 95% CI of landmark survival rate was calculated using the standard error derived from Greenwood's formula.
Analysis population: ITT population included all randomized participants, whether or not study treatment was received.
Groups in this outcome
Arm A: Pbo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm B: Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
| Group | Source count |
|---|---|
| Arm A: Pbo + Cobi + Vem | 258 |
| Arm B: Atezo + Cobi + Vem | 256 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Pbo + Cobi + Vem | 53.31 | Not reported | 47.00 | 59.62 | Not reported |
| Arm B: Atezo + Cobi + Vem | 61.50 | Not reported | 55.31 | 67.70 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.04
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0693
- param Type
- Difference in Event Free Rate
- param Value
- 8.20
- statistical Method
- Z-test
Complete source fields
- analyses
- ci Lower Limit
- -0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.04
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0693
- param Type
- Difference in Event Free Rate
- param Value
- 8.20
- statistical Method
- Z-test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 47.00
- upper Limit
- 59.62
- value
- 53.31
- group Id
- OG001
- lower Limit
- 55.31
- upper Limit
- 67.70
- value
- 61.50
- denoms
- counts
- group Id
- OG000
- value
- 258
- group Id
- OG001
- value
- 256
- units
- Participants
- description
- Percentage of participants with OS which was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate 2-year landmark survival rate. The 95% CI of landmark survival rate was calculated using the standard error derived from Greenwood's formula.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
- id
- OG000
- title
- Arm A: Pbo + Cobi + Vem
- description
- Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
- id
- OG001
- title
- Arm B: Atezo + Cobi + Vem
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants, whether or not study treatment was received.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Percentage of Participants Who Have Survived at 2 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice