TriangleNCT01996865 · OUTCOME
Overall Response Rate (ORR)
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
- From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks)
What was measured
The overall response rate (ORR) is defined as the percentage of participants with a best response of at least partial response (including complete response, complete response unconfirmed and partial response) after the first dose date of maintenance therapy and prior to any treatment change.
Analysis population: All randomized participants in Arm A and Arm B, as prespecified in the protocol
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 | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Lenalidomide + Rituximab | 85.2 | Not reported | 78.1 | 90.7 | Not reported |
| Arm B: Rituximab | 79.5 | Not reported | 71.7 | 86.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.1
- upper Limit
- 90.7
- value
- 85.2
- group Id
- OG001
- lower Limit
- 71.7
- upper Limit
- 86.1
- value
- 79.5
- denoms
- counts
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- The overall response rate (ORR) is defined as the percentage of participants with a best response of at least partial response (including complete response, complete response unconfirmed and partial response) after the first dose date of maintenance therapy and prior to any treatment change.
- 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
- NUMBER
- population Description
- All randomized participants in Arm A and Arm B, as prespecified in the protocol
- reporting Status
- POSTED
- time Frame
- From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks)
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice