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NCT01319422 · ADVERSE EVENTS

Adverse events

Continuous Versus Intermittent Dosing Regimens for Pomalidomide in Relapsed/Refractory Multiple Myeloma · Source last updated 2016-08-11

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle

Pomalidomide: Comparison of different dosages and schedules of drug

11 / 2020 / 20Not reported / Not reported
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle

Pomalidomide: Comparison of different dosages and schedules of drug

7 / 1919 / 19Not reported / Not reported

Group identifiers: EG000: Pomalidomide 4 mg/d on 21 Days/28 Day Cycle · EG001: Pomalidomide 2 mg/d on 28 Days/28 Day Cycle

Serious adverse events

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

  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Febrile neutropenia
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Lung infection
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anemia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Thrombocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Leukopenia
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Fever
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Syncope
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Dyspnea
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypoxia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Thromboembolic event
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Infection (Bacteremia)
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac Disorders, other

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      19
    term
    Leukopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Thrombocytopenia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      19
    term
    Fatigue
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Nausea
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Vomiting
  8. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    AST increased
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    ALT increased
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Diarrhea
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Myalgia
Complete source fields
event Groups
  1. description
    Pomalidomide: Comparison of different dosages and schedules of drug
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    11
    serious Num At Risk
    20
    title
    Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
  2. description
    Pomalidomide: Comparison of different dosages and schedules of drug
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    7
    serious Num At Risk
    19
    title
    Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Neutropenia
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      19
    term
    Leukopenia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      19
    term
    Thrombocytopenia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      19
    term
    Fatigue
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Nausea
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Vomiting
  8. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    AST increased
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    ALT increased
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      19
    term
    Diarrhea
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      19
    term
    Myalgia
serious Events
  1. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      19
    term
    Febrile neutropenia
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Lung infection
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anemia
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Thrombocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Leukopenia
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Fever
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Syncope
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Dyspnea
  9. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Hypoxia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Thromboembolic event
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Infection (Bacteremia)
  12. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Cardiac Disorders, other

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