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NCT03338972 · ADVERSE EVENTS

Adverse events

Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma · Source last updated 2023-09-08

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
Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year.
Other-event reporting threshold
0%

An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

5 / 77 / 74 / 7
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

8 / 88 / 83 / 8
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

5 / 77 / 70 / 7
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

3 / 33 / 30 / 3

Group identifiers: EG000: Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 · EG001: Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 · EG002: Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 · EG003: Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4

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
      3
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    NEUTROPENIC FEVER
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    NAUSEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    FEVER
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    CYTOKINE RELEASE SYNDROME
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    INFECTIONS AND INFESTATIONS - OTHER, LYSINIBACILLUS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    LUNG INFECTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    UPPER RESPIRATORY INFECTION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    ACUTE KIDNEY INJURY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    HYPOTENSION

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
      5
      num At Risk
      7
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      8
      num Events
      19
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      7
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      5
    term
    ANEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    SINUS TACHYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    DYSPHAGIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    term
    NAUSEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PANCREATITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FATIGUE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FEVER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PAIN NOS
Complete source fields
description
An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    7
    description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1
  2. deaths Num Affected
    3
    deaths Num At Risk
    8
    description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2
  3. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      8
      num Events
      19
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      7
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      5
    term
    ANEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    SINUS TACHYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    DYSPHAGIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    term
    NAUSEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PANCREATITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FATIGUE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    FEVER
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    PAIN NOS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    FEBRILE NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    NEUTROPENIC FEVER
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    NAUSEA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    FEVER
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    CYTOKINE RELEASE SYNDROME
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    INFECTIONS AND INFESTATIONS - OTHER, LYSINIBACILLUS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    LUNG INFECTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    UPPER RESPIRATORY INFECTION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    ACUTE KIDNEY INJURY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    HYPOTENSION
time Frame
Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year.

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