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NCT03043872 · ADVERSE EVENTS

Adverse events

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) · Source last updated 2026-07-16

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
All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.
Other-event reporting threshold
5%

TEAEs included those from first administration of study treatment up to and including 90 days after last dose of study treatment or up to date of initiation of the first subsequent anticancer therapy (whichever occurred first). Data from the global cohort and China cohort safety analysis sets was summarised separately. 6 patients in the China cohort were also included in the global cohort.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Global Cohort: D + T + EP

During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.

126 / 266249 / 266225 / 266
Global Cohort: D + EP

During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

86 / 265247 / 265218 / 265
Global Cohort: EP

For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.

97 / 266248 / 266247 / 266
China Cohort: D + T + EP

During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.

31 / 6565 / 6550 / 65
China Cohort: D + EP

During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

26 / 6161 / 6151 / 61
China Cohort: EP

For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.

22 / 6261 / 6255 / 62

Group identifiers: EG000: Global Cohort: D + T + EP · EG001: Global Cohort: D + EP · EG002: Global Cohort: EP · EG003: China Cohort: D + T + EP · EG004: China Cohort: D + EP · EG005: China Cohort: EP

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      266
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      265
      num Events
      8
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      266
      num Events
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      61
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      62
      num Events
      11
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      266
      num Events
      12
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      265
      num Events
      15
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      266
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Granulocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      266
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      266
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Haematotoxicity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      266
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      266
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      266
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      61
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      266
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      265
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      266
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      266
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      266
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      266
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      266
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Atrial fibrillation

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      266
      num Events
      54
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      265
      num Events
      37
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      266
      num Events
      34
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      65
      num Events
      26
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      61
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      62
      num Events
      5
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      266
      num Events
      47
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      265
      num Events
      50
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      266
      num Events
      50
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      61
      num Events
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      62
      num Events
      7
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      266
      num Events
      115
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      265
      num Events
      110
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      266
      num Events
      150
    4. group Id
      EG003
      num Affected
      47
      num At Risk
      65
      num Events
      79
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      61
      num Events
      58
    6. group Id
      EG005
      num Affected
      44
      num At Risk
      62
      num Events
      62
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      61
      num Events
      9
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      62
      num Events
      12
    term
    Bone marrow failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      266
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      265
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      266
      num Events
      6
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      61
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      266
      num Events
      69
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      265
      num Events
      87
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      266
      num Events
      69
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      65
      num Events
      73
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      61
      num Events
      65
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      62
      num Events
      69
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      266
      num Events
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      265
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      266
      num Events
      13
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      61
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      3
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      266
      num Events
      213
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      265
      num Events
      221
    3. group Id
      EG002
      num Affected
      119
      num At Risk
      266
      num Events
      234
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      65
      num Events
      50
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      61
      num Events
      40
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      62
      num Events
      55
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      266
      num Events
      68
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      265
      num Events
      63
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      266
      num Events
      83
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
      num Events
      28
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      61
      num Events
      25
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      62
      num Events
      23
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      266
      num Events
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      265
      num Events
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      266
      num Events
      1
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      266
      num Events
      33
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      265
      num Events
      26
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      266
      num Events
      4
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      65
      num Events
      14
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      266
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      265
      num Events
      16
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      266
      num Events
      8
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
      num Events
      4
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Abdominal pain upper
Complete source fields
description
TEAEs included those from first administration of study treatment up to and including 90 days after last dose of study treatment or up to date of initiation of the first subsequent anticancer therapy (whichever occurred first). Data from the global cohort and China cohort safety analysis sets was summarised separately. 6 patients in the China cohort were also included in the global cohort.
event Groups
  1. deaths Num Affected
    225
    deaths Num At Risk
    266
    description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
    id
    EG000
    other Num Affected
    249
    other Num At Risk
    266
    serious Num Affected
    126
    serious Num At Risk
    266
    title
    Global Cohort: D + T + EP
  2. deaths Num Affected
    218
    deaths Num At Risk
    265
    description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    EG001
    other Num Affected
    247
    other Num At Risk
    265
    serious Num Affected
    86
    serious Num At Risk
    265
    title
    Global Cohort: D + EP
  3. deaths Num Affected
    247
    deaths Num At Risk
    266
    description
    For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
    id
    EG002
    other Num Affected
    248
    other Num At Risk
    266
    serious Num Affected
    97
    serious Num At Risk
    266
    title
    Global Cohort: EP
  4. deaths Num Affected
    50
    deaths Num At Risk
    65
    description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
    id
    EG003
    other Num Affected
    65
    other Num At Risk
    65
    serious Num Affected
    31
    serious Num At Risk
    65
    title
    China Cohort: D + T + EP
  5. deaths Num Affected
    51
    deaths Num At Risk
    61
    description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    EG004
    other Num Affected
    61
    other Num At Risk
    61
    serious Num Affected
    26
    serious Num At Risk
    61
    title
    China Cohort: D + EP
  6. deaths Num Affected
    55
    deaths Num At Risk
    62
    description
    For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
    id
    EG005
    other Num Affected
    61
    other Num At Risk
    62
    serious Num Affected
    22
    serious Num At Risk
    62
    title
    China Cohort: EP
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      266
      num Events
      54
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      265
      num Events
      37
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      266
      num Events
      34
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      65
      num Events
      26
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      61
      num Events
      5
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      62
      num Events
      5
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      266
      num Events
      47
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      265
      num Events
      50
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      266
      num Events
      50
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      61
      num Events
      8
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      62
      num Events
      7
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      266
      num Events
      115
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      265
      num Events
      110
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      266
      num Events
      150
    4. group Id
      EG003
      num Affected
      47
      num At Risk
      65
      num Events
      79
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      61
      num Events
      58
    6. group Id
      EG005
      num Affected
      44
      num At Risk
      62
      num Events
      62
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      61
      num Events
      9
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      62
      num Events
      12
    term
    Bone marrow failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      266
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      265
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      266
      num Events
      6
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      61
      num Events
      2
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      62
      num Events
      4
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      266
      num Events
      69
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      265
      num Events
      87
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      266
      num Events
      69
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      65
      num Events
      73
    5. group Id
      EG004
      num Affected
      31
      num At Risk
      61
      num Events
      65
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      62
      num Events
      69
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      266
      num Events
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      265
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      266
      num Events
      13
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      61
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      3
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      266
      num Events
      213
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      265
      num Events
      221
    3. group Id
      EG002
      num Affected
      119
      num At Risk
      266
      num Events
      234
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      65
      num Events
      50
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      61
      num Events
      40
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      62
      num Events
      55
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      266
      num Events
      68
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      265
      num Events
      63
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      266
      num Events
      83
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      65
      num Events
      28
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      61
      num Events
      25
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      62
      num Events
      23
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      266
      num Events
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      265
      num Events
      28
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      266
      num Events
      1
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      65
      num Events
      11
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      266
      num Events
      33
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      265
      num Events
      26
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      266
      num Events
      4
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      65
      num Events
      14
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      266
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      265
      num Events
      16
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      266
      num Events
      8
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
      num Events
      4
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      61
      num Events
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      266
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      265
      num Events
      8
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      266
      num Events
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      65
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      61
      num Events
      6
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      62
      num Events
      11
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      266
      num Events
      12
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      265
      num Events
      15
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      266
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Granulocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      266
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      266
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Haematotoxicity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      266
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      62
      num Events
      2
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      266
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      266
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      61
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      62
      num Events
      3
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      266
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      265
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      266
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      266
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      266
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      62
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      266
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      266
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      266
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      265
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      266
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      65
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      61
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      62
      num Events
      0
    term
    Atrial fibrillation
time Frame
All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.

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Preserved source evidence · Not medical advice