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NCT01843374 · ADVERSE EVENTS

Adverse events

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma · Source last updated 2026-07-27

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PLACEBO

Placebo.

85 / 189159 / 189160 / 189
TREMELIMUMAB

Tremelimumab 10mg/kg

218 / 380338 / 380318 / 382

Group identifiers: EG000: PLACEBO · EG001: TREMELIMUMAB

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      380
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      380
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      189
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      380
      num Events
      7
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Atrioventricular block second degree
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      2
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      4
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Cardiac tamponade

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      189
      num Events
      37
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      380
      num Events
      76
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      189
      num Events
      14
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      380
      num Events
      18
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      189
      num Events
      31
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      380
      num Events
      54
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      189
      num Events
      62
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      380
      num Events
      82
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      189
      num Events
      49
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      380
      num Events
      368
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      189
      num Events
      50
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      380
      num Events
      126
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      17
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      380
      num Events
      91
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      189
      num Events
      28
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      380
      num Events
      75
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      189
      num Events
      72
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      380
      num Events
      119
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      189
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      380
      num Events
      21
    term
    Non-cardiac chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      16
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      380
      num Events
      45
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      18
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      380
      num Events
      81
    term
    Pyrexia
Complete source fields
event Groups
  1. deaths Num Affected
    160
    deaths Num At Risk
    189
    description
    Placebo.
    id
    EG000
    other Num Affected
    159
    other Num At Risk
    189
    serious Num Affected
    85
    serious Num At Risk
    189
    title
    PLACEBO
  2. deaths Num Affected
    318
    deaths Num At Risk
    382
    description
    Tremelimumab 10mg/kg
    id
    EG001
    other Num Affected
    338
    other Num At Risk
    380
    serious Num Affected
    218
    serious Num At Risk
    380
    title
    TREMELIMUMAB
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      189
      num Events
      37
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      380
      num Events
      76
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      189
      num Events
      14
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      380
      num Events
      18
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      189
      num Events
      31
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      380
      num Events
      54
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      189
      num Events
      62
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      380
      num Events
      82
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      189
      num Events
      49
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      380
      num Events
      368
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      189
      num Events
      50
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      380
      num Events
      126
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      17
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      380
      num Events
      91
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      189
      num Events
      28
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      380
      num Events
      75
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      189
      num Events
      72
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      380
      num Events
      119
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      189
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      380
      num Events
      21
    term
    Non-cardiac chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      16
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      380
      num Events
      45
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
      num Events
      18
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      380
      num Events
      81
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      380
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      380
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      189
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      380
      num Events
      7
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      380
      num Events
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Atrioventricular block second degree
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      2
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      380
      num Events
      4
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      380
      num Events
      0
    term
    Cardiac tamponade

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