NCT03054298 · 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
- 7 years
- Other-event reporting threshold
- 0%
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort 1 | 1 / 3 | 3 / 3 | 3 / 3 |
| Cohort 2 | 1 / 3 | 3 / 3 | 3 / 3 |
| Cohort 3 | 2 / 2 | 2 / 2 | 2 / 2 |
| Cohort 4 | 0 / 0 | 0 / 0 | 0 / 0 |
| Cohort 5 | 1 / 2 | 2 / 2 | 2 / 2 |
| Cohort 6 | 4 / 6 | 6 / 6 | 4 / 6 |
| Cohort 7 | 6 / 6 | 6 / 6 | 6 / 6 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 2
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Other (Viral gastroenteritis)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Gastroparesis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Fatigue
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 6
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Chest pain - cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 3
- num At Risk
- 6
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Supraventricular tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Ear pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Tinnitus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Other (anisocoria)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Other (burning sensation)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Eye pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal distension
Complete source fields
- description
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- event Groups
- deaths Num Affected
- 3
- deaths Num At Risk
- 3
- description
- Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG000
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Cohort 1
- deaths Num Affected
- 3
- deaths Num At Risk
- 3
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG001
- other Num Affected
- 3
- other Num At Risk
- 3
- serious Num Affected
- 1
- serious Num At Risk
- 3
- title
- Cohort 2
- deaths Num Affected
- 2
- deaths Num At Risk
- 2
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG002
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 2
- serious Num At Risk
- 2
- title
- Cohort 3
- deaths Num Affected
- 0
- deaths Num At Risk
- 0
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG003
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Cohort 4
- deaths Num Affected
- 2
- deaths Num At Risk
- 2
- description
- Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG004
- other Num Affected
- 2
- other Num At Risk
- 2
- serious Num Affected
- 1
- serious Num At Risk
- 2
- title
- Cohort 5
- deaths Num Affected
- 4
- deaths Num At Risk
- 6
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG005
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 4
- serious Num At Risk
- 6
- title
- Cohort 6
- deaths Num Affected
- 6
- deaths Num At Risk
- 6
- description
- Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- EG006
- other Num Affected
- 6
- other Num At Risk
- 6
- serious Num Affected
- 6
- serious Num At Risk
- 6
- title
- Cohort 7
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 6
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Chest pain - cardiac
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 3
- num At Risk
- 6
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Supraventricular tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Ear pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Tinnitus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Other (anisocoria)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Other (burning sensation)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Eye pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Abdominal distension
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 2
- num At Risk
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Colitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Other (Viral gastroenteritis)
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Gastroparesis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 1
- num At Risk
- 6
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 3
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 3
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG003
- num At Risk
- 0
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 2
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 6
- group Id
- EG006
- num Affected
- 0
- num At Risk
- 6
- term
- Fatigue
- time Frame
- 7 years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle