Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02119468 · ADVERSE EVENTS

Adverse events

Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2024-03-15

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
From the date of the first dose up to 2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level #1 (3mg MLN9708)

Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally

4 / 77 / 74 / 7
Dose Level #2 (4mg MLN9708)

Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally

11 / 2525 / 256 / 25

Group identifiers: EG000: Dose Level #1 (3mg MLN9708) · EG001: Dose Level #2 (4mg MLN9708)

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Skin infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      4
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Back pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Muscle weakness lower limb
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Respiratory, thoracic and mediastinal disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Rectal hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Small intestinal obstruction

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      25
      num Events
      88
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      4
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Tricuspid valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hearing impaired
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Vertigo
Complete source fields
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    7
    description
    Patients receive 3mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Dose Level #1 (3mg MLN9708)
  2. deaths Num Affected
    6
    deaths Num At Risk
    25
    description
    Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ixazomib citrate: Given orally dexamethasone: Given orally pomalidomide: Given orally
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    11
    serious Num At Risk
    25
    title
    Dose Level #2 (4mg MLN9708)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      25
      num Events
      88
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      4
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Tricuspid valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Hearing impaired
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Vertigo
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Skin infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      4
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Back pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Muscle weakness lower limb
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    term
    Respiratory, thoracic and mediastinal disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Heart failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Rectal hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Small intestinal obstruction
time Frame
From the date of the first dose up to 2 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice