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NCT04269200 · ADVERSE EVENTS

Adverse events

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer · Source last updated 2026-08-07

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
Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Other-event reporting threshold
5%

Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Global Cohort - SoC

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

73 / 236233 / 23682 / 241
Global Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

73 / 235228 / 23565 / 238
Global Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

85 / 238236 / 23852 / 239
China Cohort - SoC

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

14 / 4444 / 4412 / 44
China Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

8 / 4141 / 4111 / 43
China Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

19 / 4139 / 4114 / 42

Group identifiers: EG000: Global Cohort - SoC · EG001: Global Cohort - SoC + Durvalumab · EG002: Global Cohort - SoC + Durvalumab + Olaparib · EG003: China Cohort - SoC · EG004: China Cohort - SoC + Durvalumab · EG005: China Cohort - SoC + Durvalumab + Olaparib

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Lymphadenitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Lung abscess
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Neutropenic infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Neutropenic sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Paracancerous pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pelvic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Peritonitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      238
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia bacterial
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pseudomembranous colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      238
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Myelosuppression

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
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      238
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      236
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      235
      num Events
      5
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
      num Events
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      44
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      6
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      236
      num Events
      65
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      235
      num Events
      62
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      238
      num Events
      67
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      44
      num Events
      12
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      10
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
      num Events
      8
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
      num Events
      48
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      235
      num Events
      61
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      238
      num Events
      85
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      236
      num Events
      10
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      235
      num Events
      14
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      238
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Fall
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      236
      num Events
      28
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      235
      num Events
      19
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      238
      num Events
      17
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Infusion related reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      236
      num Events
      24
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      235
      num Events
      37
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      238
      num Events
      41
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      44
      num Events
      33
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      41
      num Events
      28
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      41
      num Events
      22
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      236
      num Events
      26
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      235
      num Events
      26
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      238
      num Events
      25
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      44
      num Events
      35
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      41
      num Events
      24
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      41
      num Events
      26
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      44
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Bile acids increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      236
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      235
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      238
      num Events
      9
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      44
      num Events
      4
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      41
      num Events
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
      num Events
      6
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      235
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      44
      num Events
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      8
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      236
      num Events
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      235
      num Events
      13
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      238
      num Events
      42
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      7
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      41
      num Events
      21
    term
    Blood creatinine increased
Complete source fields
description
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
event Groups
  1. deaths Num Affected
    82
    deaths Num At Risk
    241
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    id
    EG000
    other Num Affected
    233
    other Num At Risk
    236
    serious Num Affected
    73
    serious Num At Risk
    236
    title
    Global Cohort - SoC
  2. deaths Num Affected
    65
    deaths Num At Risk
    238
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
    id
    EG001
    other Num Affected
    228
    other Num At Risk
    235
    serious Num Affected
    73
    serious Num At Risk
    235
    title
    Global Cohort - SoC + Durvalumab
  3. deaths Num Affected
    52
    deaths Num At Risk
    239
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
    id
    EG002
    other Num Affected
    236
    other Num At Risk
    238
    serious Num Affected
    85
    serious Num At Risk
    238
    title
    Global Cohort - SoC + Durvalumab + Olaparib
  4. deaths Num Affected
    12
    deaths Num At Risk
    44
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
    id
    EG003
    other Num Affected
    44
    other Num At Risk
    44
    serious Num Affected
    14
    serious Num At Risk
    44
    title
    China Cohort - SoC
  5. deaths Num Affected
    11
    deaths Num At Risk
    43
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
    id
    EG004
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    8
    serious Num At Risk
    41
    title
    China Cohort - SoC + Durvalumab
  6. deaths Num Affected
    14
    deaths Num At Risk
    42
    description
    Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
    id
    EG005
    other Num Affected
    39
    other Num At Risk
    41
    serious Num Affected
    19
    serious Num At Risk
    41
    title
    China Cohort - SoC + Durvalumab + Olaparib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      238
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      2
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      236
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      235
      num Events
      5
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      238
      num Events
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      44
      num Events
      7
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      6
    term
    Upper respiratory tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      236
      num Events
      65
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      235
      num Events
      62
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      238
      num Events
      67
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      44
      num Events
      12
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      10
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
      num Events
      8
    term
    Urinary tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
      num Events
      48
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      235
      num Events
      61
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      238
      num Events
      85
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      41
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      236
      num Events
      10
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      235
      num Events
      14
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      238
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Fall
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      236
      num Events
      28
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      235
      num Events
      19
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      238
      num Events
      17
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Infusion related reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      236
      num Events
      24
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      235
      num Events
      37
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      238
      num Events
      41
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      44
      num Events
      33
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      41
      num Events
      28
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      41
      num Events
      22
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      236
      num Events
      26
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      235
      num Events
      26
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      238
      num Events
      25
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      44
      num Events
      35
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      41
      num Events
      24
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      41
      num Events
      26
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      44
      num Events
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      41
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Bile acids increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      236
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      235
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      238
      num Events
      9
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      44
      num Events
      4
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      41
      num Events
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      41
      num Events
      6
    term
    Blood alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      235
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      44
      num Events
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      41
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      41
      num Events
      8
    term
    Blood bilirubin increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      236
      num Events
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      235
      num Events
      13
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      238
      num Events
      42
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      41
      num Events
      7
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      41
      num Events
      21
    term
    Blood creatinine increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Lymphadenitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Lung abscess
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Neutropenic infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Neutropenic sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Paracancerous pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pelvic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Peritonitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      238
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      235
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      238
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pneumonia bacterial
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      238
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Pseudomembranous colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1, 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      235
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      238
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      41
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Myelosuppression
time Frame
Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months

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Preserved source evidence · Not medical advice