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NCT04272775 · ADVERSE EVENTS

Adverse events

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2020-03-17

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
TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44)
Other-event reporting threshold
0%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.

4 / 77 / 70 / 7
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.

2 / 77 / 70 / 7

Group identifiers: EG000: Cohort 1: Ixazomib 4.0 mg · EG001: Cohort 2: Ixazomib 4.0 mg + Lenalidomide and 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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Back pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Femoral neck fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypokalaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Retinal detachment
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Spinal compression fracture

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 (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Haemorrhoids
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Cohort 1: Ixazomib 4.0 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Cheilitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Haemorrhoids
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Back pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Bronchitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Femoral neck fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hypokalaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Retinal detachment
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Spinal compression fracture
time Frame
TEAEs are AEs that started after the first dose of study drug and no more than 29 days after the last dose of study drug (Cycle 87 Day 44)

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