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NCT02443324 · ADVERSE EVENTS

Adverse events

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer · Source last updated 2024-07-31

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
Baseline Up to 5.9 Years
Other-event reporting threshold
5%

All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

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

Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

10 / 2423 / 2421 / 24
Cohort A1

Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

15 / 2626 / 2619 / 26
Cohort A2

Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

16 / 2828 / 2817 / 28
Cohort B

Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

10 / 1716 / 1713 / 17
Cohort C

Participants with NSCLC (Second-Fourth L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

15 / 2727 / 2716 / 27
Cohort D

Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

16 / 2424 / 2418 / 24
Cohort E

Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.

14 / 2626 / 269 / 26

Group identifiers: EG000: Cohort A · EG001: Cohort A1 · EG002: Cohort A2 · EG003: Cohort B · EG004: Cohort C · EG005: Cohort D · EG006: Cohort E

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
      1
      num At Risk
      24
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    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
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Coronary artery stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      27
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Pericarditis

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
      2
      num At Risk
      24
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      16
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
      num Events
      15
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      27
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    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
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Neutropenia
  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
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Ear discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      27
      num Events
      11
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      24
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      26
      num Events
      11
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      27
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      24
      num Events
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Abdominal pain
Complete source fields
description
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    24
    description
    Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    24
    serious Num Affected
    10
    serious Num At Risk
    24
    title
    Cohort A
  2. deaths Num Affected
    19
    deaths Num At Risk
    26
    description
    Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG001
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    15
    serious Num At Risk
    26
    title
    Cohort A1
  3. deaths Num Affected
    17
    deaths Num At Risk
    28
    description
    Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG002
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    16
    serious Num At Risk
    28
    title
    Cohort A2
  4. deaths Num Affected
    13
    deaths Num At Risk
    17
    description
    Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG003
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    10
    serious Num At Risk
    17
    title
    Cohort B
  5. deaths Num Affected
    16
    deaths Num At Risk
    27
    description
    Participants with NSCLC (Second-Fourth L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG004
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    15
    serious Num At Risk
    27
    title
    Cohort C
  6. deaths Num Affected
    18
    deaths Num At Risk
    24
    description
    Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG005
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    16
    serious Num At Risk
    24
    title
    Cohort D
  7. deaths Num Affected
    9
    deaths Num At Risk
    26
    description
    Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
    id
    EG006
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    14
    serious Num At Risk
    26
    title
    Cohort E
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
      2
      num At Risk
      24
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      16
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
      num Events
      15
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      27
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    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
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Neutropenia
  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
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      28
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Ear discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      24
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      24
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      27
      num Events
      11
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
      num Events
      2
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      24
      num Events
      7
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      26
      num Events
      11
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      28
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      27
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      24
      num Events
      5
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Abdominal 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
      1
      num At Risk
      24
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    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
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      27
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Coronary artery stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      27
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      3
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      24
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      27
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    term
    Pericarditis
time Frame
Baseline Up to 5.9 Years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice