TriangleNCT05023980 · OUTCOME
Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30
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 up to 37 months
What was measured
Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
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 | 33.54 | NA | The median event rate was not reached, and the upper limit of the 95% confidence interval could not be estimated due to insufficient number of events beyond the median at time of data cutoff. |
Source statistical analyses
- ci Lower Limit
- 0.304
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.099
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.091
- p Value Comment
- The 2-sided nominal p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.578
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.304
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.099
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.091
- p Value Comment
- The 2-sided nominal p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.578
- 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 event rate was not reached, and the upper limit of the 95% confidence interval could not be estimated due to insufficient number of events beyond the median at time of data cutoff.
- group Id
- OG001
- lower Limit
- 33.54
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 141
- units
- Participants
- description
- Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
- 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 up to 37 months
- title
- Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice