NCT02360579 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- From enrollment to end of follow-up (up to 5 years)
- Other-event reporting threshold
- 5%
Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort 1 | 9 / 23 | 23 / 23 | 18 / 23 |
| Cohort 2 | 23 / 67 | 67 / 67 | 49 / 67 |
| Cohort 3 | 2 / 12 | 12 / 12 | 11 / 12 |
| Cohort 4 | 31 / 89 | 89 / 89 | 71 / 89 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 89
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 89
- term
- Neutropenia [1]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 89
- term
- Thrombocytopenia [2]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Arrhythmia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Uveitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Haematochezia
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 46
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 54
- num At Risk
- 89
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 27
- num At Risk
- 89
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 29
- num At Risk
- 89
- term
- Leukopenia [1]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 23
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 28
- num At Risk
- 89
- term
- Lymphopenia [2]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 37
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 89
- term
- Neutropenia [3]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 89
- term
- Normocytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 89
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 72
- num At Risk
- 89
- term
- Thrombocytopenia [4]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 89
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 89
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Stress cardiomyopathy
Complete source fields
- description
- Treatment-emergent adverse events (TEAEs), clinical laboratory data assessments, serious adverse events (SAEs), and adverse events (AEs) were collected and evaluated for the duration of the study until resolution or permanent sequelae. The Safety Analysis Set is defined as patients who have received TIL infusion.
- event Groups
- deaths Num Affected
- 18
- deaths Num At Risk
- 23
- description
- Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
- id
- EG000
- other Num Affected
- 23
- other Num At Risk
- 23
- serious Num Affected
- 9
- serious Num At Risk
- 23
- title
- Cohort 1
- deaths Num Affected
- 49
- deaths Num At Risk
- 67
- description
- Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
- id
- EG001
- other Num Affected
- 67
- other Num At Risk
- 67
- serious Num Affected
- 23
- serious Num At Risk
- 67
- title
- Cohort 2
- deaths Num Affected
- 11
- deaths Num At Risk
- 12
- description
- Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b).
- id
- EG002
- other Num Affected
- 12
- other Num At Risk
- 12
- serious Num Affected
- 2
- serious Num At Risk
- 12
- title
- Cohort 3
- deaths Num Affected
- 71
- deaths Num At Risk
- 89
- description
- Cryopreserved lifileucel (LN-144) (Gen 2 infusion product)
- id
- EG003
- other Num Affected
- 89
- other Num At Risk
- 89
- serious Num Affected
- 31
- serious Num At Risk
- 89
- title
- Cohort 4
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 46
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 54
- num At Risk
- 89
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 27
- num At Risk
- 89
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 29
- num At Risk
- 89
- term
- Leukopenia [1]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 23
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 28
- num At Risk
- 89
- term
- Lymphopenia [2]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 37
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 89
- term
- Neutropenia [3]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 89
- term
- Normocytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 4
- num At Risk
- 89
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 60
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 72
- num At Risk
- 89
- term
- Thrombocytopenia [4]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 89
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 13
- num At Risk
- 89
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Stress cardiomyopathy
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 89
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 89
- term
- Neutropenia [1]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Pancytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 89
- term
- Thrombocytopenia [2]
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Arrhythmia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Uveitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 89
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 23
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 67
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 12
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 89
- term
- Haematochezia
- time Frame
- From enrollment to end of follow-up (up to 5 years)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle