TriangleNCT03391466 · 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
- From first dose up to 61.8 months
What was measured
A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.
Analysis population: Participants in the Safety Analysis Set were analyzed.
Groups in this outcome
Axicabtagene Ciloleucel
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0.
Standard of Care Therapy
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours infusion on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours infusion on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
| Group | Source count |
|---|---|
| Axicabtagene Ciloleucel | 170 |
| Standard of Care Therapy | 168 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care Therapy | 100.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 170
- group Id
- OG001
- value
- 168
- units
- Participants
- description
- A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.
- groups
- description
- Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG000
- title
- Axicabtagene Ciloleucel
- description
- Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours infusion on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours infusion on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
- id
- OG001
- title
- Standard of Care Therapy
- param Type
- NUMBER
- population Description
- Participants in the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- From first dose up to 61.8 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