Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03433001 · ADVERSE EVENTS

Adverse events

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone · Source last updated 2023-12-07

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 36 months as a maximum
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 + Lenalidomide + Dexamethasone

Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.

96 / 295225 / 29524 / 295

Group identifiers: EG000: Ixazomib + 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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Cardiac failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Cardio-respiratory arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      295
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Colitis ischaemic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Crohn's disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Enteritis

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/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      295
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      295
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      295
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      295
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      295
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      295
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      295
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      295
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      295
    term
    Platelet count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      295
    term
    White blood cell count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      295
    term
    Rash
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
    24
    deaths Num At Risk
    295
    description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    EG000
    other Num Affected
    225
    other Num At Risk
    295
    serious Num Affected
    96
    serious Num At Risk
    295
    title
    Ixazomib + Lenalidomide + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      295
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      295
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      295
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      295
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      295
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      295
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      295
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      295
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      295
    term
    Platelet count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      295
    term
    White blood cell count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      295
    term
    Rash
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Cardiac failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      295
    term
    Cardio-respiratory arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Cardiac failure acute
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      295
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Colitis ischaemic
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Crohn's disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA/J v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      295
    term
    Enteritis
time Frame
Up to 36 months as a maximum

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

Preserved source evidence · Not medical advice