TriangleNCT01996865 · OUTCOME
Time to Histological Transformation
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 first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks)
What was measured
Time to histological transformation is defined as from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation (as assessed by the investigator). Analysis was based on Kaplan Meier estimates. In case of clinical suspicion of transformation, including rapid disease progression, unexpected changes in "B" symptoms or rapidly increasing LDH, a biopsy should be performed. In this clinical trial, histological transformation will be considered disease progression. This endpoint will not be calculated for participants randomized with transformed Follicular Lymphoma (tFL).
Analysis population: All randomized participants in Arm A and Arm B without transformed Follicular Lymphoma (tFL)
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 | 133 |
| Arm B: Rituximab | 129 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Lenalidomide + Rituximab | NA | Not reported | NA | NA | Median, lower and upper limit not calculated due to insufficient number of events. |
| Arm B: Rituximab | NA | Not reported | NA | NA | Median, lower and upper limit not calculated due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median, lower and upper limit not calculated due to insufficient number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median, lower and upper limit not calculated due to insufficient number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 129
- units
- Participants
- description
- Time to histological transformation is defined as from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation (as assessed by the investigator). Analysis was based on Kaplan Meier estimates. In case of clinical suspicion of transformation, including rapid disease progression, unexpected changes in "B" symptoms or rapidly increasing LDH, a biopsy should be performed. In this clinical trial, histological transformation will be considered disease progression. This endpoint will not be calculated for participants randomized with transformed Follicular Lymphoma (tFL).
- 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
- All randomized participants in Arm A and Arm B without transformed Follicular Lymphoma (tFL)
- reporting Status
- POSTED
- time Frame
- From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks)
- title
- Time to Histological Transformation
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice