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NCT05537766 · ADVERSE EVENTS

Adverse events

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Source last updated 2026-03-10

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
Up to 2 years
Other-event reporting threshold
5%

All-cause mortality: The full analysis set included all enrolled participants (the participants who had leukapheresis) Adverse Events: The safety analysis set is defined as all participants treated with any dose of brexucabtagene autoleucel. As no participants were enrolled in Substudy A and no dose was received, data for adverse events is reported only for Substudies B, C, and D.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel

Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg IV on Day 0.

3 / 44 / 43 / 6
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel

Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg IV on Day 0.

6 / 1010 / 105 / 12
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel

Participant with Relapsed/Refractory Hairy Cell Leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg IV on Day 0.

0 / 11 / 10 / 1

Group identifiers: EG000: Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel · EG001: Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel · EG002: Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel

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
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Haemolysis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Haemophagocytic lymphohistiocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia cytomegaloviral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pseudomonal sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Septic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Tumour lysis syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Muscle mass
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Aphasia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Apraxia

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
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Hypofibrinogenaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Ventricular arrhythmia
Complete source fields
description
All-cause mortality: The full analysis set included all enrolled participants (the participants who had leukapheresis) Adverse Events: The safety analysis set is defined as all participants treated with any dose of brexucabtagene autoleucel. As no participants were enrolled in Substudy A and no dose was received, data for adverse events is reported only for Substudies B, C, and D.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg IV on Day 0.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
  2. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg IV on Day 0.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participant with Relapsed/Refractory Hairy Cell Leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg IV on Day 0.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Hypofibrinogenaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Sinus bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    term
    Ventricular arrhythmia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Haemolysis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Haemophagocytic lymphohistiocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pneumonia cytomegaloviral
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Pseudomonal sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Septic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Tumour lysis syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Muscle mass
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Aphasia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    term
    Apraxia
time Frame
Up to 2 years

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Preserved source evidence · Not medical advice