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NCT02654132 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) · Source last updated 2022-11-01

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
All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)
Other-event reporting threshold
5%

All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
E-Pd Cohort

Elotuzumab + Pomalidomide + Dexamethasone

42 / 6056 / 6041 / 60
Pd Cohort

Pomalidomide + Dexamethasone

33 / 5549 / 5541 / 57

Group identifiers: EG000: E-Pd Cohort · EG001: Pd Cohort

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
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    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
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
    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
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Angina unstable
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    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
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract subcapsular

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
      17
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      55
    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
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    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
      6
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    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
      16
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
    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
      9
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
    term
    Asthenia
Complete source fields
description
All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
event Groups
  1. deaths Num Affected
    41
    deaths Num At Risk
    60
    description
    Elotuzumab + Pomalidomide + Dexamethasone
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    60
    serious Num Affected
    42
    serious Num At Risk
    60
    title
    E-Pd Cohort
  2. deaths Num Affected
    41
    deaths Num At Risk
    57
    description
    Pomalidomide + Dexamethasone
    id
    EG001
    other Num Affected
    49
    other Num At Risk
    55
    serious Num Affected
    33
    serious Num At Risk
    55
    title
    Pd Cohort
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
      17
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      55
    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
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    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
      6
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    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
      16
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
    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
      9
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
    term
    Asthenia
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
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    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
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
    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
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Angina unstable
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cardiac disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    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
      60
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      60
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cataract subcapsular
time Frame
All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)

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