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NCT01673867 · ADVERSE EVENTS

Adverse events

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC · Source last updated 2023-02-08

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
Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).
Other-event reporting threshold
5%

All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Nivolumab 3 mg/kg

Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

172 / 287267 / 287258 / 292
Nivolumab 480 mg

Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

5 / 1512 / 152 / 15
Docetaxel

Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

161 / 268258 / 268266 / 290
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg

Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

9 / 1712 / 1714 / 17
Extension Phase of Docetaxel Arm: Nivolumab 480 mg

Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

1 / 11 / 10 / 1

Group identifiers: EG000: Nivolumab 3 mg/kg · EG001: Nivolumab 480 mg · EG002: Docetaxel · EG003: Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg · EG004: Extension Phase of Docetaxel Arm: Nivolumab 480 mg

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
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thrombotic thrombocytopenic purpura
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardio-respiratory arrest

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
    24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
Complete source fields
description
All-Cause Mortality = all randomized participants. Serious Adverse Events and Other Adverse Events = all treated participants. ARM 1: AEs that occurred on 3 mg/kg Nivolumab, ARM 2: AEs that occurred on 480 mg Nivolumab, ARM 3: AEs that occurred on Docetaxel treatment only, ARM 4: Extension phase of Docetaxel arm: AEs that occurred on 3 mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab.
event Groups
  1. deaths Num Affected
    258
    deaths Num At Risk
    292
    description
    Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    EG000
    other Num Affected
    267
    other Num At Risk
    287
    serious Num Affected
    172
    serious Num At Risk
    287
    title
    Nivolumab 3 mg/kg
  2. deaths Num Affected
    2
    deaths Num At Risk
    15
    description
    Nivolumab 480 mg solution administered intravenously every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Nivolumab 480 mg
  3. deaths Num Affected
    266
    deaths Num At Risk
    290
    description
    Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    EG002
    other Num Affected
    258
    other Num At Risk
    268
    serious Num Affected
    161
    serious Num At Risk
    268
    title
    Docetaxel
  4. deaths Num Affected
    14
    deaths Num At Risk
    17
    description
    Eligible participants from the Docetaxel arm who transitioned to nivolumab 3 mg/kg every 2 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    EG003
    other Num Affected
    12
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Eligible participants from the Docetaxel arm who transitioned to nivolumab 480 mg every 4 weeks via extension phase. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Extension Phase of Docetaxel Arm: Nivolumab 480 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thrombotic thrombocytopenic purpura
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      287
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      268
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardio-respiratory arrest
time Frame
Participants were assessed for all-cause mortality from randomization until study completion (up to approximately 110 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 108 months).

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Preserved source evidence · Not medical advice