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NCT04334759 · ADVERSE EVENTS

Adverse events

DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma · Source last updated 2026-10-01

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
AEs will be recorded from randomisation until 30 days after the last dose of chemotherapy or until 90 days after the last dose of durvalumab, ipilimumab or nivolumab, whichever is longer. The median of the observation period for all-cause mortality is 33.9 months with range (3.1 months - 44.6 months).
Other-event reporting threshold
0%

Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, other important medical events which, in the opinion of the investigator, are likely to become serious if untreated, or as defined in the protocol. The adverse events analysis population is comprised of treated patients.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance

Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab

50 / 112111 / 11281 / 112
Control Arm for Chemo Cohort: Chemotherapy, Then Observation

Standard Chemotherapy for 4 to 6 cycles, followed by Observation

20 / 5552 / 5541 / 55
Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance

Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab

8 / 1717 / 178 / 17
Control Arm for IO Cohort: Ipilimumab and Nivolumab

Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.

13 / 2323 / 235 / 23

Group identifiers: EG000: Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance · EG001: Control Arm for Chemo Cohort: Chemotherapy, Then Observation · EG002: Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance · EG003: Control Arm for IO Cohort: Ipilimumab and Nivolumab

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
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Myocarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    DIABETIC KETOACIDOSIS

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
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      112
      num Events
      43
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      55
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    ELEVATED PLATELET COUNT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    IRON DEFICIENCY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    PROTEIN C DEFICIENCY
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    THROMBOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      112
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
Complete source fields
description
Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, other important medical events which, in the opinion of the investigator, are likely to become serious if untreated, or as defined in the protocol. The adverse events analysis population is comprised of treated patients.
event Groups
  1. deaths Num Affected
    81
    deaths Num At Risk
    112
    description
    Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
    id
    EG000
    other Num Affected
    111
    other Num At Risk
    112
    serious Num Affected
    50
    serious Num At Risk
    112
    title
    Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
  2. deaths Num Affected
    41
    deaths Num At Risk
    55
    description
    Standard Chemotherapy for 4 to 6 cycles, followed by Observation
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    55
    serious Num Affected
    20
    serious Num At Risk
    55
    title
    Control Arm for Chemo Cohort: Chemotherapy, Then Observation
  3. deaths Num Affected
    8
    deaths Num At Risk
    17
    description
    Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    8
    serious Num At Risk
    17
    title
    Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
  4. deaths Num Affected
    5
    deaths Num At Risk
    23
    description
    Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
    id
    EG003
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    13
    serious Num At Risk
    23
    title
    Control Arm for IO Cohort: Ipilimumab and Nivolumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      112
      num Events
      43
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      55
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      17
      num Events
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    ELEVATED PLATELET COUNT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    IRON DEFICIENCY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    PROTEIN C DEFICIENCY
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    THROMBOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      112
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Chest pain - cardiac
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      17
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      112
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Myocarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      17
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      112
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      112
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      17
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    DIABETIC KETOACIDOSIS
time Frame
AEs will be recorded from randomisation until 30 days after the last dose of chemotherapy or until 90 days after the last dose of durvalumab, ipilimumab or nivolumab, whichever is longer. The median of the observation period for all-cause mortality is 33.9 months with range (3.1 months - 44.6 months).

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