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NCT02547662 · ADVERSE EVENTS

Adverse events

Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia · Source last updated 2023-10-30

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 were followed for 4 years and 1 month, mortality was followed for 4 years and 8 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)

Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO

5 / 1717 / 173 / 17

Group identifiers: EG000: Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)

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
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Infections and infestations - Oth spec
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      4
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Upper respiratory infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ankle fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      3
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Back pain

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
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      17
      num Events
      47
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      6
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      17
      num Events
      55
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
      num Events
      6
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      17
      num Events
      13
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Edema limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      17
      num Events
      102
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    term
    Ankle fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      17
      num Events
      39
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
      num Events
      7
    term
    Lymphocyte count decreased
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    17
    description
    Patients receive ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Ixazomib Citrate: Given PO Laboratory Biomarker Analysis: Correlative studies Pomalidomide: Given PO
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    5
    serious Num At Risk
    17
    title
    Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      17
      num Events
      47
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      6
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      17
      num Events
      55
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
      num Events
      6
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      17
      num Events
      13
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Edema limbs
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      17
      num Events
      102
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      4
    term
    Ankle fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      17
      num Events
      39
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
      num Events
      7
    term
    Lymphocyte count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Infections and infestations - Oth spec
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      4
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Upper respiratory infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Ankle fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Alanine aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      3
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Back pain
time Frame
Adverse events were followed for 4 years and 1 month, mortality was followed for 4 years and 8 months.

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