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NCT04222972 · ADVERSE EVENTS

Adverse events

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-03-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to approximately 50 months
Other-event reporting threshold
5%

All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Treatment Period- SOC

Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.

38 / 104103 / 10427 / 113
Arm B: Treatment Period- Pralsetinib

Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).

67 / 108106 / 10833 / 110
Arm C: Crossover Period- Pralsetinib

Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).

22 / 3838 / 388 / 38

Group identifiers: EG000: Arm A: Treatment Period- SOC · EG001: Arm B: Treatment Period- Pralsetinib · EG002: Arm C: Crossover Period- Pralsetinib

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 version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Pericardial effusion

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 version 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      104
      num Events
      63
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      108
      num Events
      71
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      38
      num Events
      13
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      108
      num Events
      16
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      4
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      104
      num Events
      31
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      108
      num Events
      46
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
      num Events
      23
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      104
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      104
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
      num Events
      5
    term
    Eyelid oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Lacrimation increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      108
      num Events
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
      num Events
      4
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Abdominal pain upper
Complete source fields
description
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    113
    description
    Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
    id
    EG000
    other Num Affected
    103
    other Num At Risk
    104
    serious Num Affected
    38
    serious Num At Risk
    104
    title
    Arm A: Treatment Period- SOC
  2. deaths Num Affected
    33
    deaths Num At Risk
    110
    description
    Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
    id
    EG001
    other Num Affected
    106
    other Num At Risk
    108
    serious Num Affected
    67
    serious Num At Risk
    108
    title
    Arm B: Treatment Period- Pralsetinib
  3. deaths Num Affected
    8
    deaths Num At Risk
    38
    description
    Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
    id
    EG002
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    22
    serious Num At Risk
    38
    title
    Arm C: Crossover Period- Pralsetinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      104
      num Events
      63
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      108
      num Events
      71
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      38
      num Events
      13
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      108
      num Events
      16
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      4
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      104
      num Events
      31
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      108
      num Events
      46
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      38
      num Events
      23
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      104
      num Events
      17
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      104
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      38
      num Events
      5
    term
    Eyelid oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Lacrimation increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      108
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
      num Events
      9
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      108
      num Events
      11
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      38
      num Events
      4
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      104
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      108
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      104
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      104
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Pericardial effusion
time Frame
Up to approximately 50 months

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Preserved source evidence · Not medical advice