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NCT01642004 · ADVERSE EVENTS

Adverse events

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) · Source last updated 2022-12-28

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 their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 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 3mg/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 3mg/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 intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

85 / 131120 / 131119 / 135
Nivolumab 480 mg

Nivolumab 480 mg solution intravenously every 4 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

1 / 64 / 62 / 6
Docetaxel

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

92 / 129123 / 129129 / 137
Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg

Eligible patients from the Docetaxel arm may receive nivolumab 3 mg/kg every 2 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

4 / 64 / 65 / 6
Extension Phase of Docetaxel Arm: Nivolumab 480 mg

Eligible patients from the Docetaxel arm may receive nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

0 / 11 / 11 / 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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac tamponade

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chills
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 3mg/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 3mg/kg Nivolumab, ARM 5: Extension phase of Docetaxel arm: AEs that occurred on or 480 mg Nivolumab
event Groups
  1. deaths Num Affected
    119
    deaths Num At Risk
    135
    description
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    EG000
    other Num Affected
    120
    other Num At Risk
    131
    serious Num Affected
    85
    serious Num At Risk
    131
    title
    Nivolumab 3 mg/kg
  2. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Nivolumab 480 mg solution intravenously every 4 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Nivolumab 480 mg
  3. deaths Num Affected
    129
    deaths Num At Risk
    137
    description
    Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression , discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    EG002
    other Num Affected
    123
    other Num At Risk
    129
    serious Num Affected
    92
    serious Num At Risk
    129
    title
    Docetaxel
  4. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Eligible patients from the Docetaxel arm may receive nivolumab 3 mg/kg every 2 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Extension Phase of Docetaxel Arm: Nivolumab 3 mg/kg
  5. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Eligible patients from the Docetaxel arm may receive nivolumab 480 mg flat dose every 4 weeks via extension phase until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Chills
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial flutter
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Atrial thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      129
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    term
    Cardiac tamponade
time Frame
Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 103 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 94 months).

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Preserved source evidence · Not medical advice