TriangleNCT05023980 · OUTCOME
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
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 death from any cause (up to 41 months)
What was measured
Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff.
Analysis population: All randomized participants.
Groups in this outcome
Arm A - Pirtobrutinib
Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
Arm B - Bendamustine Plus Rituximab
Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
| Group | Source count |
|---|---|
| Arm A - Pirtobrutinib | 141 |
| Arm B - Bendamustine Plus Rituximab | 141 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Pirtobrutinib | NA | Not reported | NA | NA | The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff. |
| Arm B - Bendamustine Plus Rituximab | NA | Not reported | NA | NA | The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff. |
Source statistical analyses
- ci Lower Limit
- 0.070
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.934
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0261
- p Value Comment
- The 2-sided p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.257
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.070
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.934
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0261
- p Value Comment
- The 2-sided p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.257
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 141
- units
- Participants
- description
- Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A - Pirtobrutinib
- description
- Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
- id
- OG001
- title
- Arm B - Bendamustine Plus Rituximab
- param Type
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until death from any cause (up to 41 months)
- title
- Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7
Preserved source evidence · Not medical advice