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NCT02823574 · ADVERSE EVENTS

Adverse events

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment A - Platinum Refractory Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

103 / 158139 / 158131 / 159
Treatment B - Platinum Refractory Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

52 / 8276 / 8271 / 82
Treatment A - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W

89 / 122118 / 122102 / 123
Treatment B - Platinum Eligible Subgroup

Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W

35 / 6154 / 6149 / 61

Group identifiers: EG000: Treatment A - Platinum Refractory Subgroup · EG001: Treatment B - Platinum Refractory Subgroup · EG002: Treatment A - Platinum Eligible Subgroup · EG003: Treatment B - Platinum Eligible Subgroup

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
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    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
      2
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Febrile bone marrow aplasia
  3. 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
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Lymph node pain
  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
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Vestibular disorder

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
      41
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      61
    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
      12
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      61
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      61
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      61
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      61
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      61
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      61
    term
    Nausea
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
event Groups
  1. deaths Num Affected
    131
    deaths Num At Risk
    159
    description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    EG000
    other Num Affected
    139
    other Num At Risk
    158
    serious Num Affected
    103
    serious Num At Risk
    158
    title
    Treatment A - Platinum Refractory Subgroup
  2. deaths Num Affected
    71
    deaths Num At Risk
    82
    description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    EG001
    other Num Affected
    76
    other Num At Risk
    82
    serious Num Affected
    52
    serious Num At Risk
    82
    title
    Treatment B - Platinum Refractory Subgroup
  3. deaths Num Affected
    102
    deaths Num At Risk
    123
    description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
    id
    EG002
    other Num Affected
    118
    other Num At Risk
    122
    serious Num Affected
    89
    serious Num At Risk
    122
    title
    Treatment A - Platinum Eligible Subgroup
  4. deaths Num Affected
    49
    deaths Num At Risk
    61
    description
    Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
    id
    EG003
    other Num Affected
    54
    other Num At Risk
    61
    serious Num Affected
    35
    serious Num At Risk
    61
    title
    Treatment B - Platinum Eligible Subgroup
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
      41
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      61
    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
      12
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      61
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      61
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      61
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      61
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      61
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      61
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      61
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      61
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      61
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      61
    term
    Nausea
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
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    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
      2
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Febrile bone marrow aplasia
  3. 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
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Lymph node pain
  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
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Pericardial effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      82
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      122
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      61
    term
    Vestibular disorder
time Frame
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months

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Preserved source evidence · Not medical advice