Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01564537 · ADVERSE EVENTS

Adverse events

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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 signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months
Other-event reporting threshold
5%

The investigator had to document any occurrence of adverse events including abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of the relation to study treatment. Safety population included all randomized participants who received at least 1 dose of any study drug, regardless of their randomized treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ixazomib+ Lenalidomide + Dexamethasone

Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).

205 / 361350 / 361250 / 361
Placebo + Lenalidomide + Dexamethasone

Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

202 / 359342 / 359251 / 359

Group identifiers: EG000: Ixazomib+ Lenalidomide + Dexamethasone · EG001: Placebo + Lenalidomide + Dexamethasone

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain lower
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abscess limb
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Accidental overdose
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      359
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      359
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute polyneuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute respiratory distress syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute vestibular syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Adenocarcinoma of colon

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      359
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      359
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      359
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      359
    term
    Anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      359
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      359
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      359
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      359
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      359
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      359
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      359
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      359
    term
    Conjunctivitis
Complete source fields
description
The investigator had to document any occurrence of adverse events including abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of the relation to study treatment. Safety population included all randomized participants who received at least 1 dose of any study drug, regardless of their randomized treatment.
event Groups
  1. deaths Num Affected
    250
    deaths Num At Risk
    361
    description
    Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
    id
    EG000
    other Num Affected
    350
    other Num At Risk
    361
    serious Num Affected
    205
    serious Num At Risk
    361
    title
    Ixazomib+ Lenalidomide + Dexamethasone
  2. deaths Num Affected
    251
    deaths Num At Risk
    359
    description
    Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
    id
    EG001
    other Num Affected
    342
    other Num At Risk
    359
    serious Num Affected
    202
    serious Num At Risk
    359
    title
    Placebo + Lenalidomide + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      359
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      359
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      359
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      359
    term
    Anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      359
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      359
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      359
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      359
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      359
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      359
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      359
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      359
    term
    Conjunctivitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain lower
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Abscess limb
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      359
    term
    Accidental overdose
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      359
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      359
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute polyneuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute respiratory distress syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Acute vestibular syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      361
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      359
    term
    Adenocarcinoma of colon
time Frame
From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months

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

Preserved source evidence · Not medical advice