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NCT03777657 · ADVERSE EVENTS

Adverse events

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma · Source last updated 2025-02-14

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
From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
Other-event reporting threshold
3%

All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tislelizumab + Chemotherapy

Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

211 / 498489 / 498397 / 501
Placebo + Chemotherapy

Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

179 / 494485 / 494431 / 496

Group identifiers: EG000: Tislelizumab + Chemotherapy · EG001: Placebo + Chemotherapy

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      498
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      494
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      494
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Immune thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      494
      num Events
      4
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      498
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Coronary artery occlusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Left ventricular failure

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      197
      num At Risk
      498
      num Events
      374
    2. group Id
      EG001
      num Affected
      202
      num At Risk
      494
      num Events
      355
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      498
      num Events
      193
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      494
      num Events
      123
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      498
      num Events
      247
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      494
      num Events
      184
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      498
      num Events
      131
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      494
      num Events
      101
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      498
      num Events
      73
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      494
      num Events
      13
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      498
      num Events
      21
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      494
      num Events
      25
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      498
      num Events
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      494
      num Events
      9
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      498
      num Events
      61
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      494
      num Events
      59
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      498
      num Events
      109
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      494
      num Events
      97
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      498
      num Events
      62
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      494
      num Events
      80
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      498
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      494
      num Events
      10
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      498
      num Events
      123
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      494
      num Events
      144
    term
    Constipation
Complete source fields
description
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
event Groups
  1. deaths Num Affected
    397
    deaths Num At Risk
    501
    description
    Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    489
    other Num At Risk
    498
    serious Num Affected
    211
    serious Num At Risk
    498
    title
    Tislelizumab + Chemotherapy
  2. deaths Num Affected
    431
    deaths Num At Risk
    496
    description
    Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    485
    other Num At Risk
    494
    serious Num Affected
    179
    serious Num At Risk
    494
    title
    Placebo + Chemotherapy
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      197
      num At Risk
      498
      num Events
      374
    2. group Id
      EG001
      num Affected
      202
      num At Risk
      494
      num Events
      355
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      498
      num Events
      193
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      494
      num Events
      123
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      498
      num Events
      247
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      494
      num Events
      184
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      498
      num Events
      131
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      494
      num Events
      101
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      498
      num Events
      73
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      494
      num Events
      13
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      498
      num Events
      21
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      494
      num Events
      25
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      498
      num Events
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      494
      num Events
      9
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      498
      num Events
      61
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      494
      num Events
      59
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      498
      num Events
      109
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      494
      num Events
      97
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      498
      num Events
      62
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      494
      num Events
      80
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      498
      num Events
      18
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      494
      num Events
      10
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      498
      num Events
      123
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      494
      num Events
      144
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      498
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      494
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      494
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Immune thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      494
      num Events
      4
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      498
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      498
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      494
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Coronary artery occlusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      498
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      494
      num Events
      1
    term
    Left ventricular failure
time Frame
From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.

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