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NCT02312258 · ADVERSE EVENTS

Adverse events

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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
First dose of study drug through 30 days after last dose of study drug (up to 88 months)
Other-event reporting threshold
5%

All-cause mortality= ITT Population included all participants who were randomized and had post-randomization data. Serious and Other Adverse Events: Safety population included all participants who received at least 1 dose of ixazomib or placebo. Three participants assigned to placebo arm each received a single 3 mg dose of ixazomib. These participants were excluded from the placebo arm and included in the ixazomib arm in the safety population.

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

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

48 / 276188 / 276115 / 281
Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

101 / 426340 / 426184 / 425

Group identifiers: EG000: Placebo · EG001: Ixazomib

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 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      426
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Abdominal wall abscess
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      426
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Acute pulmonary oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Adenocarcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Adenocarcinoma of colon
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Angioedema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Ascites

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 25
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      426
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      426
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      426
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      426
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      426
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      426
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      426
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      426
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      426
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      426
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      426
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      426
    term
    Headache
Complete source fields
description
All-cause mortality= ITT Population included all participants who were randomized and had post-randomization data. Serious and Other Adverse Events: Safety population included all participants who received at least 1 dose of ixazomib or placebo. Three participants assigned to placebo arm each received a single 3 mg dose of ixazomib. These participants were excluded from the placebo arm and included in the ixazomib arm in the safety population.
event Groups
  1. deaths Num Affected
    115
    deaths Num At Risk
    281
    description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    EG000
    other Num Affected
    188
    other Num At Risk
    276
    serious Num Affected
    48
    serious Num At Risk
    276
    title
    Placebo
  2. deaths Num Affected
    184
    deaths Num At Risk
    425
    description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    EG001
    other Num Affected
    340
    other Num At Risk
    426
    serious Num Affected
    101
    serious Num At Risk
    426
    title
    Ixazomib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      426
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      426
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      426
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      426
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      426
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      426
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      426
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      426
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      426
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      426
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      426
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      426
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      426
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Abdominal wall abscess
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      426
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Acute pulmonary oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Adenocarcinoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Adenocarcinoma of colon
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      426
    term
    Angioedema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Arthralgia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      276
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      426
    term
    Ascites
time Frame
First dose of study drug through 30 days after last dose of study drug (up to 88 months)

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