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NCT02181413 · ADVERSE EVENTS

Adverse events

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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
Randomization up to end of follow up period (107 months)
Other-event reporting threshold
5%

All cause-mortality: ITT Population was defined as all participants who were randomized and had post randomization data. Serious and Other Adverse Events: Safety Population was defined as participants who received at least 1 dose of ixazomib citrate or placebo.

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

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.

51 / 259229 / 25993 / 261
Ixazomib Citrate

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.

108 / 394371 / 394144 / 395

Group identifiers: EG000: Placebo · EG001: Ixazomib Citrate

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Adenocarcinoma of colon
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Ankle fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Ankylosing spondylitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Atypical pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      394
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Bacterial 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 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      394
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      394
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      394
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      394
    term
    Bone pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      394
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      394
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      394
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      394
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      394
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      394
    term
    Dizziness
Complete source fields
description
All cause-mortality: ITT Population was defined as all participants who were randomized and had post randomization data. Serious and Other Adverse Events: Safety Population was defined as participants who received at least 1 dose of ixazomib citrate or placebo.
event Groups
  1. deaths Num Affected
    93
    deaths Num At Risk
    261
    description
    Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
    id
    EG000
    other Num Affected
    229
    other Num At Risk
    259
    serious Num Affected
    51
    serious Num At Risk
    259
    title
    Placebo
  2. deaths Num Affected
    144
    deaths Num At Risk
    395
    description
    Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
    id
    EG001
    other Num Affected
    371
    other Num At Risk
    394
    serious Num Affected
    108
    serious Num At Risk
    394
    title
    Ixazomib Citrate
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      394
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      394
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      394
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      394
    term
    Bone pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      394
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      394
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      394
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      394
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      394
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      394
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      394
    term
    Dizziness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Adenocarcinoma of colon
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Ankle fracture
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Ankylosing spondylitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      394
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Atypical pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      394
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      259
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      394
    term
    Bacterial infection
time Frame
Randomization up to end of follow up period (107 months)

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