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NCT05116189 · ADVERSE EVENTS

Adverse events

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). · Source last updated 2026-03-09

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
Up to approximately 38 months
Other-event reporting threshold
5%

All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab + Paclitaxel ± Bevacizumab

Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

178 / 320319 / 320225 / 322
Placebo + Paclitaxel ± Bevacizumab

Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

122 / 318307 / 318244 / 321

Group identifiers: EG000: Pembrolizumab + Paclitaxel ± Bevacizumab · EG001: Placebo + Paclitaxel ± Bevacizumab

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      318
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      2
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      3
    term
    Myelosuppression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Coronary artery stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Immune-mediated myocarditis

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      320
      num Events
      365
    2. group Id
      EG001
      num Affected
      148
      num At Risk
      318
      num Events
      263
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      320
      num Events
      77
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      318
      num Events
      100
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      320
      num Events
      186
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      318
      num Events
      205
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      320
      num Events
      67
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      318
      num Events
      23
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      320
      num Events
      30
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      318
      num Events
      29
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      320
      num Events
      95
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      318
      num Events
      109
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      320
      num Events
      22
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      318
      num Events
      31
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      320
      num Events
      103
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      318
      num Events
      102
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      320
      num Events
      285
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      318
      num Events
      252
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      320
      num Events
      26
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      318
      num Events
      32
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      320
      num Events
      32
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      318
      num Events
      19
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      320
      num Events
      229
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      318
      num Events
      170
    term
    Nausea
Complete source fields
description
All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
event Groups
  1. deaths Num Affected
    225
    deaths Num At Risk
    322
    description
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    EG000
    other Num Affected
    319
    other Num At Risk
    320
    serious Num Affected
    178
    serious Num At Risk
    320
    title
    Pembrolizumab + Paclitaxel ± Bevacizumab
  2. deaths Num Affected
    244
    deaths Num At Risk
    321
    description
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    EG001
    other Num Affected
    307
    other Num At Risk
    318
    serious Num Affected
    122
    serious Num At Risk
    318
    title
    Placebo + Paclitaxel ± Bevacizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      320
      num Events
      365
    2. group Id
      EG001
      num Affected
      148
      num At Risk
      318
      num Events
      263
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      320
      num Events
      77
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      318
      num Events
      100
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      320
      num Events
      186
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      318
      num Events
      205
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      320
      num Events
      67
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      318
      num Events
      23
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      320
      num Events
      30
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      318
      num Events
      29
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      320
      num Events
      95
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      318
      num Events
      109
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      320
      num Events
      22
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      318
      num Events
      31
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      320
      num Events
      103
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      318
      num Events
      102
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      320
      num Events
      285
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      318
      num Events
      252
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      320
      num Events
      26
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      318
      num Events
      32
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      320
      num Events
      32
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      318
      num Events
      19
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      320
      num Events
      229
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      318
      num Events
      170
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      318
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      2
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      3
    term
    Myelosuppression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      318
      num Events
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      318
      num Events
      1
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Coronary artery stenosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      318
      num Events
      0
    term
    Immune-mediated myocarditis
time Frame
Up to approximately 38 months

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Preserved source evidence · Not medical advice