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NCT03792633 · ADVERSE EVENTS

Adverse events

Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL · Source last updated 2025-06-05

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
1 year
Other-event reporting threshold
5%

Adverse events were collected from only those subjects who were given the intervention.

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

Newly Diagnosed VHR B-ALL or High-Risk Relapse of B

45 / 5252 / 522 / 55
Cohort B

Poor Response to Prior B Cell Directed Engineered cell therapy

32 / 4846 / 480 / 51

Group identifiers: EG000: Cohort A · EG001: Cohort B

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
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      52
      num Events
      65
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      48
      num Events
      35
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Ventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Eye disorders - Other (Right soft tissue orbital mass)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Dysphagia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Gastrointestinal disorders - Other (Gastrointestinal hemorrhage)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      52
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      48
      num Events
      10
    term
    Fever

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
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      5
    term
    Sinus bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Ear Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      5
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      2
    term
    Photophobia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      52
      num Events
      119
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      48
      num Events
      79
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      52
      num Events
      60
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      48
      num Events
      50
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
      num Events
      28
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      48
      num Events
      14
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      48
      num Events
      20
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      52
      num Events
      29
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      48
      num Events
      22
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      52
      num Events
      105
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      48
      num Events
      48
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Oral hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Oral pain
Complete source fields
description
Adverse events were collected from only those subjects who were given the intervention.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    55
    description
    Newly Diagnosed VHR B-ALL or High-Risk Relapse of B
    id
    EG000
    other Num Affected
    52
    other Num At Risk
    52
    serious Num Affected
    45
    serious Num At Risk
    52
    title
    Cohort A
  2. deaths Num Affected
    0
    deaths Num At Risk
    51
    description
    Poor Response to Prior B Cell Directed Engineered cell therapy
    id
    EG001
    other Num Affected
    46
    other Num At Risk
    48
    serious Num Affected
    32
    serious Num At Risk
    48
    title
    Cohort B
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      5
    term
    Sinus bradycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Ear Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      5
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      2
    term
    Photophobia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      52
      num Events
      119
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      48
      num Events
      79
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      52
      num Events
      60
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      48
      num Events
      50
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
      num Events
      28
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      48
      num Events
      14
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      48
      num Events
      20
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      52
      num Events
      29
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      48
      num Events
      22
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      52
      num Events
      105
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      48
      num Events
      48
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Oral hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Oral pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      52
      num Events
      65
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      48
      num Events
      35
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Left ventricular systolic dysfunction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Ventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Eye disorders - Other (Right soft tissue orbital mass)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Dysphagia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Gastrointestinal disorders - Other (Gastrointestinal hemorrhage)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Chills
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      52
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      48
      num Events
      10
    term
    Fever
time Frame
1 year

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