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NCT02765854 · ADVERSE EVENTS

Adverse events

Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement · Source last updated 2025-06-26

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
1 year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Ixazomib and Dexamethasone)

UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO

20 / 2720 / 271 / 27
Arm B (Ixazomib and Dexamethasone)

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO

10 / 2210 / 220 / 22
Arm C (Ixazomib, Dexamethasone, Lenalidomide)

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO

10 / 2116 / 210 / 21

Group identifiers: EG000: Arm A (Ixazomib and Dexamethasone) · EG001: Arm B (Ixazomib and Dexamethasone) · EG002: Arm C (Ixazomib, Dexamethasone, 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
    notes
    suspected myocardial infarction.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anxiety
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Acute Renal Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Bone Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Hypertension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    presumed
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Cardiopulmonary Arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Conjunctivtis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Multisystem Organ Failure
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Dehydration

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
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Agitation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Altered Mental Status
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Bone Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cardiopulmonary Arrest, Presumed
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cellulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Conjunctivits
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    27
    description
    UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone. Dexamethasone: Given PO Ixazomib: Given PO
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    27
    serious Num Affected
    20
    serious Num At Risk
    27
    title
    Arm A (Ixazomib and Dexamethasone)
  2. deaths Num Affected
    0
    deaths Num At Risk
    22
    description
    MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A. Dexamethasone: Given PO Ixazomib: Given PO
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    22
    serious Num Affected
    10
    serious Num At Risk
    22
    title
    Arm B (Ixazomib and Dexamethasone)
  3. deaths Num Affected
    0
    deaths Num At Risk
    21
    description
    MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21. Dexamethasone: Given PO Ixazomib: Given PO Lenalidomide: Given PO
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    21
    serious Num Affected
    10
    serious Num At Risk
    21
    title
    Arm C (Ixazomib, Dexamethasone, Lenalidomide)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Agitation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Altered Mental Status
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Bone Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cardiopulmonary Arrest, Presumed
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Cellulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
    term
    Conjunctivits
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    suspected myocardial infarction.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Anxiety
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Acute Renal Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Bone Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Hypertension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    presumed
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Cardiopulmonary Arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    cellulitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Conjunctivtis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Multisystem Organ Failure
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    term
    Dehydration
time Frame
1 year

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

Preserved source evidence · Not medical advice