TriangleNCT01996865 · OUTCOME
Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
What was measured
Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment.
Analysis population: All treated participants
Groups in this outcome
Induction Period: Lenalidomide + Rituximab
Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
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 |
|---|---|
| Induction Period: Lenalidomide + Rituximab | 500 |
| Arm A: Lenalidomide + Rituximab | 134 |
| Arm B: Rituximab | 132 |
Reported measurements
Participants experiencing at least one TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Induction Period: Lenalidomide + Rituximab | 499 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Lenalidomide + Rituximab | 133 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Rituximab | 120 | Not reported | Not reported | Not reported | Not reported |
Participants experiencing at least one serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Induction Period: Lenalidomide + Rituximab | 172 | Not reported | Not reported | Not reported | Not reported |
| Arm A: Lenalidomide + Rituximab | 57 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Rituximab | 22 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 499
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 120
- title
- Participants experiencing at least one TEAE
- categories
- measurements
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 22
- title
- Participants experiencing at least one serious TEAE
- denoms
- counts
- group Id
- OG000
- value
- 500
- group Id
- OG001
- value
- 134
- group Id
- OG002
- value
- 132
- units
- Participants
- description
- Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment.
- groups
- description
- Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
- id
- OG000
- title
- Induction Period: Lenalidomide + Rituximab
- 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
- OG001
- 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
- OG002
- title
- Arm B: Rituximab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
- title
- Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice