TriangleNCT03484702 · OUTCOME
Number of Participants With Adverse Events 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
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) 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
AEs 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 5 | 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 |
AEs 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 | 29 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 8 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
AEs 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 | 36 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 26 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 5 | Not reported | Not reported | Not reported | Not reported |
AEs 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 | 25 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Primary Central Nervous System Lymphoma | 3 | Not reported | Not reported | Not reported | Not reported |
AEs 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 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2 | 7 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- 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
- AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 4
- 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
- AEs occurring between LDC and JCAR017 infusion
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- 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
- AEs occurring between JCAR017 infusion and Day 30
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- 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
- AEs occurring between Day 31 and Day 90
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- 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
- AEs 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
- An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) 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 Adverse Events 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