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NCT03054298 · ADVERSE EVENTS

Adverse events

CAR T Cells in Mesothelin Expressing Cancers · Source last updated 2025-04-29

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.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

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..

1 / 33 / 33 / 3
Cohort 2

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..

1 / 33 / 33 / 3
Cohort 3

PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

2 / 22 / 22 / 2
Cohort 4

PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..

0 / 00 / 00 / 0
Cohort 5

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..

1 / 22 / 22 / 2
Cohort 6

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..

4 / 66 / 64 / 6
Cohort 7

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..

6 / 66 / 66 / 6

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Cohort 4 · EG004: Cohort 5 · EG005: Cohort 6 · EG006: Cohort 7

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Other (Viral gastroenteritis)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Gastroparesis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Edema limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Fatigue

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Other (anisocoria)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Other (burning sensation)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Eye pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      6
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Other (anisocoria)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Other (burning sensation)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Eye pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Abdominal distension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Other (Viral gastroenteritis)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Gastroparesis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Edema limbs
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Fatigue
time Frame
7 years

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Preserved source evidence · Not medical advice