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NCT03036098 · ADVERSE EVENTS

Adverse events

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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 the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).
Other-event reporting threshold
5%

All-Cause Mortality represents all randomized participants. 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 1

Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study

264 / 345322 / 345257 / 349
Treatment 2

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study

170 / 328309 / 328294 / 357
Treatment 3

Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study

168 / 304298 / 304172 / 304
Treatment 4

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study

130 / 301295 / 301193 / 304

Group identifiers: EG000: Treatment 1 · EG001: Treatment 2 · EG002: Treatment 3 · EG003: Treatment 4

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      301
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      301
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Bicytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Cytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Febrile bone marrow aplasia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      301
    term
    Febrile neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Immune-mediated pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Leukopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      301
    term
    Myelosuppression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      301
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Pancytopenia

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      193
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      170
      num At Risk
      301
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      301
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      301
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      301
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      301
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      301
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      92
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      301
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      301
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      301
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      159
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      161
      num At Risk
      301
    term
    Nausea
Complete source fields
description
All-Cause Mortality represents all randomized participants. 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
    257
    deaths Num At Risk
    349
    description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    EG000
    other Num Affected
    322
    other Num At Risk
    345
    serious Num Affected
    264
    serious Num At Risk
    345
    title
    Treatment 1
  2. deaths Num Affected
    294
    deaths Num At Risk
    357
    description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    EG001
    other Num Affected
    309
    other Num At Risk
    328
    serious Num Affected
    170
    serious Num At Risk
    328
    title
    Treatment 2
  3. deaths Num Affected
    172
    deaths Num At Risk
    304
    description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    EG002
    other Num Affected
    298
    other Num At Risk
    304
    serious Num Affected
    168
    serious Num At Risk
    304
    title
    Treatment 3
  4. deaths Num Affected
    193
    deaths Num At Risk
    304
    description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    EG003
    other Num Affected
    295
    other Num At Risk
    301
    serious Num Affected
    130
    serious Num At Risk
    301
    title
    Treatment 4
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      193
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      170
      num At Risk
      301
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      301
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      104
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      301
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      38
      num At Risk
      301
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      301
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      301
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      92
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      86
      num At Risk
      301
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      46
      num At Risk
      301
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      301
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      159
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      161
      num At Risk
      301
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      301
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      301
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Bicytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Cytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Febrile bone marrow aplasia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      301
    term
    Febrile neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Immune-mediated pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Leukopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      301
    term
    Myelosuppression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      301
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      328
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      304
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      301
    term
    Pancytopenia
time Frame
Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).

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Preserved source evidence · Not medical advice