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NCT03391466 · ADVERSE EVENTS

Adverse events

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

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
All-cause mortality and Adverse events: Up to 74.9 months
Other-event reporting threshold
5%

All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Axicabtagene Ciloleucel Treatment

Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

96 / 170170 / 17081 / 180
Standard of Care Therapy

Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.

78 / 168166 / 168101 / 179
Retreatment Axicabtagene Ciloleucel

Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg.

2 / 1010 / 103 / 10

Group identifiers: EG000: Axicabtagene Ciloleucel Treatment · EG001: Standard of Care Therapy · EG002: Retreatment Axicabtagene Ciloleucel

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
      2
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. 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
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiac arrest
  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
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Heart failure with reduced ejection fraction

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
      71
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    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
      170
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      9
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    term
    Diarrhoea
Complete source fields
description
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
event Groups
  1. deaths Num Affected
    81
    deaths Num At Risk
    180
    description
    Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    EG000
    other Num Affected
    170
    other Num At Risk
    170
    serious Num Affected
    96
    serious Num At Risk
    170
    title
    Axicabtagene Ciloleucel Treatment
  2. deaths Num Affected
    101
    deaths Num At Risk
    179
    description
    Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
    id
    EG001
    other Num Affected
    166
    other Num At Risk
    168
    serious Num Affected
    78
    serious Num At Risk
    168
    title
    Standard of Care Therapy
  3. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Retreatment Axicabtagene Ciloleucel
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
      71
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    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
      170
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      9
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    term
    Diarrhoea
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
      2
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Febrile neutropenia
  4. 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
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    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
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiac arrest
  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
      170
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      170
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      168
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    term
    Heart failure with reduced ejection fraction
time Frame
All-cause mortality and Adverse events: Up to 74.9 months

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Preserved source evidence · Not medical advice