TriangleNCT03484702 · OUTCOME
Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
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 leukapheresis to end of study (up to approximately 63 months)
What was measured
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
Analysis population: All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
Groups in this outcome
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
Cohort 5: Primary Central Nervous System Lymphoma
JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 36 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
Reported measurements
SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 36 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
SAEs occurring between LDC and JCAR017 infusion
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 36 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
SAEs occurring between JCAR017 infusion and Day 30
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 36 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 16 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
SAEs occurring between Day 31 and Day 90
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 35 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 27 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
SAEs occurring between Day 91 and end of study
| Group | Source count |
|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 32 |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 23 |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 8 |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- SAEs occurring between LDC and JCAR017 infusion
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- SAEs occurring between JCAR017 infusion and Day 30
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- SAEs occurring between Day 31 and Day 90
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- SAEs occurring between Day 91 and end of study
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
- groups
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG000
- title
- Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG001
- title
- Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG002
- title
- Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG003
- title
- Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
- description
- JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
- id
- OG004
- title
- Cohort 5: Primary Central Nervous System Lymphoma
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants in the JCAR017 treated set. Prespecified to be reported for cohorts 1, 2, 3, 4, and 5 only
- reporting Status
- POSTED
- time Frame
- From leukapheresis to end of study (up to approximately 63 months)
- title
- Number of Participants With Serious Adverse Events (SAEs) in Cohorts 1, 2, 3, 4, and 5
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice