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NCT01864018 · ADVERSE EVENTS

Adverse events

Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis · Source last updated 2025-07-24

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
5 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I/II, Cohort A

Questionnaire Administration: Ancillary studies

16 / 4848 / 482 / 48
Phase II, Cohort B

Questionnaire Administration: Ancillary studies

15 / 3535 / 357 / 35

Group identifiers: EG000: Phase I/II, Cohort A · EG001: Phase II, Cohort B

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 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Chest pain - cardiac
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Ventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Gastric hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Death NOS

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 12.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      2
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Hearing impaired
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      48
      num Events
      179
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      35
      num Events
      68
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      48
      num Events
      115
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      35
      num Events
      48
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Duodenal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Gastroesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Gastrointestinal disorders - Oth spec
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    48
    description
    Questionnaire Administration: Ancillary studies
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    16
    serious Num At Risk
    48
    title
    Phase I/II, Cohort A
  2. deaths Num Affected
    7
    deaths Num At Risk
    35
    description
    Questionnaire Administration: Ancillary studies
    id
    EG001
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    15
    serious Num At Risk
    35
    title
    Phase II, Cohort B
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      35
      num Events
      3
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      2
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Hearing impaired
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Cataract
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      48
      num Events
      179
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      35
      num Events
      68
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      48
      num Events
      115
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      35
      num Events
      48
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Duodenal ulcer
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Gastroesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Gastrointestinal disorders - Oth spec
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Chest pain - cardiac
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Pericarditis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Ventricular tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Gastric hemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      35
      num Events
      0
    term
    Pancreatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      48
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Death NOS
time Frame
5 years

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