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NCT03797326 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) · Source last updated 2026-05-04

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 66 months
Other-event reporting threshold
5%

All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)

Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

16 / 3130 / 3127 / 31
Cohort B: Ovarian Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

19 / 3131 / 3128 / 31
Cohort C: Gastric Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

57 / 9995 / 9997 / 102
Cohort D1: Colorectal Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

55 / 105103 / 10597 / 107
Cohort D2: Colorectal Cancer (Lenva)

Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

12 / 3029 / 3030 / 32
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

30 / 10198 / 10199 / 102
Cohort F: Biliary Tract Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

62 / 102100 / 10298 / 103
Cohort G: Pancreatic Cancer (Lenva + Pembro)

Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.

49 / 103101 / 103101 / 103

Group identifiers: EG000: Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) · EG001: Cohort B: Ovarian Cancer (Lenva + Pembro) · EG002: Cohort C: Gastric Cancer (Lenva + Pembro) · EG003: Cohort D1: Colorectal Cancer (Lenva + Pembro) · EG004: Cohort D2: Colorectal Cancer (Lenva) · EG005: Cohort E: Glioblastoma Multiforma (Lenva + Pembro) · EG006: Cohort F: Biliary Tract Cancer (Lenva + Pembro) · EG007: Cohort G: Pancreatic Cancer (Lenva + Pembro)

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
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      103
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Haemolytic uraemic syndrome
  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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Pancytopenia
  5. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Thrombotic microangiopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      103
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      99
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Hypersensitivity myocarditis

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
      5
      num At Risk
      31
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      5
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      20
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      105
      num Events
      19
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      30
      num Events
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      102
      num Events
      13
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      103
      num Events
      17
    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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      99
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      105
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      101
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      103
      num Events
      2
    term
    Leukopenia
  3. 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
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      99
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      101
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      102
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      103
      num Events
      5
    term
    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
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      99
      num Events
      14
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      105
      num Events
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      102
      num Events
      5
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      103
      num Events
      13
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      99
      num Events
      6
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      105
      num Events
      9
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      102
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      103
      num Events
      3
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      31
      num Events
      15
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      31
      num Events
      14
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      99
      num Events
      25
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      105
      num Events
      53
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      30
      num Events
      13
    6. group Id
      EG005
      num Affected
      28
      num At Risk
      101
      num Events
      30
    7. group Id
      EG006
      num Affected
      34
      num At Risk
      102
      num Events
      35
    8. group Id
      EG007
      num Affected
      28
      num At Risk
      103
      num Events
      29
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      31
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      99
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      105
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      102
      num Events
      4
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      103
      num Events
      6
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
      num Events
      11
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      19
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      105
      num Events
      28
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      101
      num Events
      14
    7. group Id
      EG006
      num Affected
      32
      num At Risk
      102
      num Events
      44
    8. group Id
      EG007
      num Affected
      29
      num At Risk
      103
      num Events
      34
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      99
      num Events
      7
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      105
      num Events
      9
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      101
      num Events
      4
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      102
      num Events
      10
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      103
      num Events
      8
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      99
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      102
      num Events
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      103
      num Events
      4
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      31
      num Events
      11
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      18
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      105
      num Events
      25
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      101
      num Events
      15
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      102
      num Events
      27
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      103
      num Events
      24
    term
    Constipation
Complete source fields
description
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    31
    description
    Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    16
    serious Num At Risk
    31
    title
    Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
  2. deaths Num Affected
    28
    deaths Num At Risk
    31
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    19
    serious Num At Risk
    31
    title
    Cohort B: Ovarian Cancer (Lenva + Pembro)
  3. deaths Num Affected
    97
    deaths Num At Risk
    102
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG002
    other Num Affected
    95
    other Num At Risk
    99
    serious Num Affected
    57
    serious Num At Risk
    99
    title
    Cohort C: Gastric Cancer (Lenva + Pembro)
  4. deaths Num Affected
    97
    deaths Num At Risk
    107
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG003
    other Num Affected
    103
    other Num At Risk
    105
    serious Num Affected
    55
    serious Num At Risk
    105
    title
    Cohort D1: Colorectal Cancer (Lenva + Pembro)
  5. deaths Num Affected
    30
    deaths Num At Risk
    32
    description
    Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG004
    other Num Affected
    29
    other Num At Risk
    30
    serious Num Affected
    12
    serious Num At Risk
    30
    title
    Cohort D2: Colorectal Cancer (Lenva)
  6. deaths Num Affected
    99
    deaths Num At Risk
    102
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG005
    other Num Affected
    98
    other Num At Risk
    101
    serious Num Affected
    30
    serious Num At Risk
    101
    title
    Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
  7. deaths Num Affected
    98
    deaths Num At Risk
    103
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG006
    other Num Affected
    100
    other Num At Risk
    102
    serious Num Affected
    62
    serious Num At Risk
    102
    title
    Cohort F: Biliary Tract Cancer (Lenva + Pembro)
  8. deaths Num Affected
    101
    deaths Num At Risk
    103
    description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    EG007
    other Num Affected
    101
    other Num At Risk
    103
    serious Num Affected
    49
    serious Num At Risk
    103
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
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
      5
      num At Risk
      31
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      5
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      20
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      105
      num Events
      19
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      30
      num Events
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      102
      num Events
      13
    8. group Id
      EG007
      num Affected
      15
      num At Risk
      103
      num Events
      17
    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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      99
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      105
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      101
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      103
      num Events
      2
    term
    Leukopenia
  3. 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
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      99
      num Events
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      101
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      102
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      103
      num Events
      5
    term
    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
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      3
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      99
      num Events
      14
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      105
      num Events
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      102
      num Events
      5
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      103
      num Events
      13
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      31
      num Events
      2
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      99
      num Events
      6
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      105
      num Events
      9
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      101
      num Events
      8
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      102
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      103
      num Events
      3
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      31
      num Events
      15
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      31
      num Events
      14
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      99
      num Events
      25
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      105
      num Events
      53
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      30
      num Events
      13
    6. group Id
      EG005
      num Affected
      28
      num At Risk
      101
      num Events
      30
    7. group Id
      EG006
      num Affected
      34
      num At Risk
      102
      num Events
      35
    8. group Id
      EG007
      num Affected
      28
      num At Risk
      103
      num Events
      29
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      31
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      99
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      105
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      102
      num Events
      4
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      103
      num Events
      6
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      31
      num Events
      11
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      19
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      105
      num Events
      28
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
      num Events
      7
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      101
      num Events
      14
    7. group Id
      EG006
      num Affected
      32
      num At Risk
      102
      num Events
      44
    8. group Id
      EG007
      num Affected
      29
      num At Risk
      103
      num Events
      34
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      31
      num Events
      10
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      99
      num Events
      7
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      105
      num Events
      9
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      101
      num Events
      4
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      102
      num Events
      10
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      103
      num Events
      8
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      31
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      99
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      102
      num Events
      6
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      103
      num Events
      4
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      31
      num Events
      11
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      99
      num Events
      18
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      105
      num Events
      25
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
      num Events
      3
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      101
      num Events
      15
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      102
      num Events
      27
    8. group Id
      EG007
      num Affected
      19
      num At Risk
      103
      num Events
      24
    term
    Constipation
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
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      105
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      103
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Haemolytic uraemic syndrome
  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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Pancytopenia
  5. 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
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Thrombotic microangiopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      103
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      31
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      99
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      99
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      102
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      31
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      99
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      105
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      101
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      102
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      103
      num Events
      0
    term
    Hypersensitivity myocarditis
time Frame
Up to approximately 66 months

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Preserved source evidence · Not medical advice