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NCT02389517 · ADVERSE EVENTS

Adverse events

Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant · Source last updated 2026-01-22

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 2 years after the end of treatment visit, ** up to 2.5 years**
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)

Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). Ixazomib Citrate: Given PO Lenalidomide: Given PO Dexamethasone: Given PO

5 / 2020 / 200 / 20
Arm II (Lenalidomide)

Patients receive lenalidomide PO as in Arm I. Lenalidomide: Given PO

2 / 2219 / 220 / 22

Group identifiers: EG000: Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone) · EG001: Arm II (Lenalidomide)

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Bronchospasm
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Infections and infestations - others
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Neoplasms benign, malignant and unspecified - others
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Respiratory, thoracic and mediastinal disorders- others
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Upper respiratory infection

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
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Allergic rhinitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Bloating
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    20
    description
    Patients receive ixazomib citrate PO on days 1, 8, and 15, lenalidomide PO QD on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22 (of courses 1-4 only). Ixazomib Citrate: Given PO Lenalidomide: Given PO Dexamethasone: Given PO
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone)
  2. deaths Num Affected
    0
    deaths Num At Risk
    22
    description
    Patients receive lenalidomide PO as in Arm I. Lenalidomide: Given PO
    id
    EG001
    other Num Affected
    19
    other Num At Risk
    22
    serious Num Affected
    2
    serious Num At Risk
    22
    title
    Arm II (Lenalidomide)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Allergic rhinitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Bloating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Bronchospasm
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Fever
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Fracture
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Infections and infestations - others
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Lung infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Neoplasms benign, malignant and unspecified - others
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Respiratory, thoracic and mediastinal disorders- others
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Upper respiratory infection
time Frame
Up to 2 years after the end of treatment visit, ** up to 2.5 years**

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Preserved source evidence · Not medical advice