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NCT03012880 · ADVERSE EVENTS

Adverse events

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2025-06-04

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
2 years
Other-event reporting threshold
0%

All registered patients that were evaluated are included.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A

MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.

10 / 3939 / 394 / 39
Cohort B

MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.

8 / 4040 / 401 / 40

Group identifiers: EG000: Cohort A · EG001: 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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Glaucoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Multi-organ failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Appendicitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Infections and infestations - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Lung infection

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
      4
      num At Risk
      39
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      40
      num Events
      25
    term
    Anemia
  2. 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
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Eye disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      21
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dental caries
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      39
      num Events
      212
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      40
      num Events
      230
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Gastrointestinal disorders - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      39
      num Events
      122
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
      num Events
      167
    term
    Nausea
Complete source fields
description
All registered patients that were evaluated are included.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    39
    description
    MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    10
    serious Num At Risk
    39
    title
    Cohort A
  2. deaths Num Affected
    1
    deaths Num At Risk
    40
    description
    MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    8
    serious Num At Risk
    40
    title
    Cohort B
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
      4
      num At Risk
      39
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      40
      num Events
      25
    term
    Anemia
  2. 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
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Eye disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      21
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dental caries
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      39
      num Events
      212
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      40
      num Events
      230
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastroesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Gastrointestinal disorders - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      39
      num Events
      122
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
      num Events
      167
    term
    Nausea
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
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Glaucoma
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Multi-organ failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Appendicitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Infections and infestations - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Lung infection
time Frame
2 years

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