TriangleNCT03105336 · OUTCOME
Percentage of 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 85.6 months
What was measured
TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off.
Analysis population: Participants in the Safety Analysis Set were analyzed.
Groups in this outcome
Axicabtagene Ciloleucel (Follicular Lymphoma)
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
| Group | Source count |
|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 124 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 99 | Not reported | Not reported | Not reported | Not reported |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off.
- groups
- description
- Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG000
- title
- Axicabtagene Ciloleucel (Follicular Lymphoma)
- description
- Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG001
- title
- Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
- param Type
- NUMBER
- population Description
- Participants in the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 85.6 months
- title
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice