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NCT03575351 · ADVERSE EVENTS

Adverse events

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03

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
Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 60 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (Up to 16.5 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants. Randomized SOC (92) for All-Cause Mortality is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified Treated SOC (91) for SAEs and Other AEs is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SOC Arm (Pre-crossover Only)

Participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). 1 cycle = 3 weeks

21 / 3030 / 309 / 31
Liso-cel Arm Only

\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

43 / 9292 / 9234 / 92
SOC-JCAR017 Arm Pre- and Post-Crossover (All Crossed)

participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). Participants crossed over to JCAR017 regardless of if they received CAR T therapy or not.

19 / 6157 / 6133 / 61

Group identifiers: EG000: SOC Arm (Pre-crossover Only) · EG001: Liso-cel Arm Only · EG002: SOC-JCAR017 Arm Pre- and Post-Crossover (All Crossed)

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Cytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      61
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Pericarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Postural orthostatic tachycardia syndrome

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      61
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      61
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      61
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
    term
    Abdominal pain
Complete source fields
description
The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and Other AEs=All treated participants. Randomized SOC (92) for All-Cause Mortality is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified Treated SOC (91) for SAEs and Other AEs is presented separately under "SOC pre-crossover only" and "SOC-JCAR017 Pre- and post-cross over" arms as pre-specified
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    31
    description
    Participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). 1 cycle = 3 weeks
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    21
    serious Num At Risk
    30
    title
    SOC Arm (Pre-crossover Only)
  2. deaths Num Affected
    34
    deaths Num At Risk
    92
    description
    \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
    id
    EG001
    other Num Affected
    92
    other Num At Risk
    92
    serious Num Affected
    43
    serious Num At Risk
    92
    title
    Liso-cel Arm Only
  3. deaths Num Affected
    33
    deaths Num At Risk
    61
    description
    participants received 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). Participants crossed over to JCAR017 regardless of if they received CAR T therapy or not.
    id
    EG002
    other Num Affected
    57
    other Num At Risk
    61
    serious Num Affected
    19
    serious Num At Risk
    61
    title
    SOC-JCAR017 Arm Pre- and Post-Crossover (All Crossed)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      61
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      61
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      61
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      61
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      61
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Cytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      61
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Pericarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      61
    term
    Postural orthostatic tachycardia syndrome
time Frame
Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 60 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (Up to 16.5 months).

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Preserved source evidence · Not medical advice