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NCT02917941 · ADVERSE EVENTS

Adverse events

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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
Up to approximately 33 months
Other-event reporting threshold
5%

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
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.

12 / 3434 / 343 / 34

Group identifiers: EG000: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

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
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pneumonia
  2. 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
      34
    term
    Cellulitis
  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
      34
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Inguinal hernia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Fall
  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
      34
    term
    Subdural haemorrhage
  9. 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
      34
    term
    Femoral neck fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Blood creatine phosphokinase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Erythema multiforme

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 (21.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      34
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Abdominal pain upper
  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
      34
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Haemorrhoids
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      34
    term
    Upper respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
    term
    Nasopharyngitis
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
    3
    deaths Num At Risk
    34
    description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    12
    serious Num At Risk
    34
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      34
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      34
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Abdominal pain upper
  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
      34
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Haemorrhoids
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      34
    term
    Upper respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      34
    term
    Nasopharyngitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
    term
    Pneumonia
  2. 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
      34
    term
    Cellulitis
  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
      34
    term
    Influenza
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Inguinal hernia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
    term
    Fall
  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
      34
    term
    Subdural haemorrhage
  9. 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
      34
    term
    Femoral neck fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Blood creatine phosphokinase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (21.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
    term
    Erythema multiforme
time Frame
Up to approximately 33 months

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