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NCT02726581 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma · Source last updated 2023-03-27

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
AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 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
Arm A: N-Pd

Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

52 / 7270 / 7247 / 75
Arm B: Pd

Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

41 / 7065 / 7049 / 71
Arm C: NE-Pd

Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.

18 / 2424 / 2417 / 24
Arm B: NE-Pd Crossover

Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.

5 / 87 / 85 / 8

Group identifiers: EG000: Arm A: N-Pd · EG001: Arm B: Pd · EG002: Arm C: NE-Pd · EG003: Arm B: NE-Pd Crossover

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    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
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Neutropenia
  4. 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
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrioventricular block first degree
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Myocardial infarction

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
      26
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    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
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Vitreous detachment
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
    47
    deaths Num At Risk
    75
    description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    EG000
    other Num Affected
    70
    other Num At Risk
    72
    serious Num Affected
    52
    serious Num At Risk
    72
    title
    Arm A: N-Pd
  2. deaths Num Affected
    49
    deaths Num At Risk
    71
    description
    Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
    id
    EG001
    other Num Affected
    65
    other Num At Risk
    70
    serious Num Affected
    41
    serious Num At Risk
    70
    title
    Arm B: Pd
  3. deaths Num Affected
    17
    deaths Num At Risk
    24
    description
    Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: * Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. * Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. * Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. * Participants \</= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. * Participants \> 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.
    id
    EG002
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    18
    serious Num At Risk
    24
    title
    Arm C: NE-Pd
  4. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    Arm B: NE-Pd Crossover
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
      26
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    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
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Vitreous detachment
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    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
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Neutropenia
  4. 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
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrioventricular block complete
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Atrioventricular block first degree
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    term
    Myocardial infarction
time Frame
AEs and SAEs assessed from first dose to 100 days post last dose (up to approximately 63 months). Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).

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Preserved source evidence · Not medical advice