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NCT02220894 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042) · Source last updated 2026-06-25

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 93 months
Other-event reporting threshold
5%

Population: All participants receiving ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab

Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)

261 / 636535 / 636528 / 637
Chemotherapy (SOC Treatment)

Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W.

193 / 615577 / 615582 / 637
Pembrolizumab Second Course

Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

8 / 3421 / 3418 / 34

Group identifiers: EG000: Pembrolizumab · EG001: Chemotherapy (SOC Treatment) · EG002: Pembrolizumab Second Course

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      636
      num Events
      3
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      615
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      615
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      615
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      636
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      636
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      615
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      636
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      615
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      615
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      636
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Pyrexia

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      636
      num Events
      124
    2. group Id
      EG001
      num Affected
      253
      num At Risk
      615
      num Events
      332
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      636
      num Events
      17
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      615
      num Events
      63
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      636
      num Events
      9
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      615
      num Events
      177
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      636
      num Events
      7
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      615
      num Events
      86
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      636
      num Events
      38
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      615
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      636
      num Events
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      615
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      5
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      636
      num Events
      98
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      615
      num Events
      168
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      636
      num Events
      94
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      615
      num Events
      107
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      636
      num Events
      98
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      615
      num Events
      407
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      636
      num Events
      62
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      615
      num Events
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      636
      num Events
      92
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      615
      num Events
      110
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      636
      num Events
      61
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      615
      num Events
      52
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Chest pain
Complete source fields
description
Population: All participants receiving ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    528
    deaths Num At Risk
    637
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 Q3W for a maximum of 35 cycles (21-day cycles)
    id
    EG000
    other Num Affected
    535
    other Num At Risk
    636
    serious Num Affected
    261
    serious Num At Risk
    636
    title
    Pembrolizumab
  2. deaths Num Affected
    582
    deaths Num At Risk
    637
    description
    Participants received carboplatin at target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W.
    id
    EG001
    other Num Affected
    577
    other Num At Risk
    615
    serious Num Affected
    193
    serious Num At Risk
    615
    title
    Chemotherapy (SOC Treatment)
  3. deaths Num Affected
    18
    deaths Num At Risk
    34
    description
    Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    EG002
    other Num Affected
    21
    other Num At Risk
    34
    serious Num Affected
    8
    serious Num At Risk
    34
    title
    Pembrolizumab Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      636
      num Events
      124
    2. group Id
      EG001
      num Affected
      253
      num At Risk
      615
      num Events
      332
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      636
      num Events
      17
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      615
      num Events
      63
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      636
      num Events
      9
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      615
      num Events
      177
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      636
      num Events
      7
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      615
      num Events
      86
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      636
      num Events
      38
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      615
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      636
      num Events
      99
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      615
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      5
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      636
      num Events
      98
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      615
      num Events
      168
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      636
      num Events
      94
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      615
      num Events
      107
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      636
      num Events
      98
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      615
      num Events
      407
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      636
      num Events
      62
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      615
      num Events
      167
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      636
      num Events
      92
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      615
      num Events
      110
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      636
      num Events
      61
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      615
      num Events
      52
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Chest pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      636
      num Events
      3
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      615
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      636
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      615
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      615
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Coronary artery disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      636
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      636
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      615
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      636
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      615
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      615
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      636
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      615
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      636
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      615
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Pyrexia
time Frame
Up to approximately 93 months

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Preserved source evidence · Not medical advice