TriangleNCT01996865 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)
What was measured
DOR is from initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. Analysis was based on Kaplan Meier estimates.
Analysis population: The analysis is only performed for participants who have achieved PR or better after the first dose date of maintenance therapy and prior to any treatment change. Arm B includes 3 additional participants who achieved CR/CRu/PR in the follow-up period.
Groups in this outcome
Arm A: Lenalidomide + Rituximab
Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
Arm B: Rituximab
Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
| Group | Source count |
|---|---|
| Arm A: Lenalidomide + Rituximab | 115 |
| Arm B: Rituximab | 108 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Lenalidomide + Rituximab | 268.3 | Not reported | 168.0 | NA | Upper limit not calculated due to insufficient number of events |
| Arm B: Rituximab | 306.0 | Not reported | 183.7 | NA | Upper limit not calculated due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit not calculated due to insufficient number of events
- group Id
- OG000
- lower Limit
- 168.0
- upper Limit
- NA
- value
- 268.3
- comment
- Upper limit not calculated due to insufficient number of events
- group Id
- OG001
- lower Limit
- 183.7
- upper Limit
- NA
- value
- 306.0
- denoms
- counts
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 108
- units
- Participants
- description
- DOR is from initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. Analysis was based on Kaplan Meier estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
- id
- OG000
- title
- Arm A: Lenalidomide + Rituximab
- description
- Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
- id
- OG001
- title
- Arm B: Rituximab
- param Type
- MEDIAN
- population Description
- The analysis is only performed for participants who have achieved PR or better after the first dose date of maintenance therapy and prior to any treatment change. Arm B includes 3 additional participants who achieved CR/CRu/PR in the follow-up period.
- reporting Status
- POSTED
- time Frame
- From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice