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NCT02516423 · ADVERSE EVENTS

Adverse events

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone · Source last updated 2026-06-30

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
5 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid

zoledronic acid: IV

3 / 55 / 51 / 5
Zoledronic Acid

zoledronic acid: IV

1 / 65 / 60 / 6

Group identifiers: EG000: Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid · EG001: Zoledronic Acid

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 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypophosphatemia

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 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      5
      num Events
      21
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      12
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      9
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Flu like symptoms
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    INR increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Investigations - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      5
      num Events
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      11
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      7
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypophosphatemia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    zoledronic acid: IV
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    zoledronic acid: IV
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Zoledronic Acid
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      5
      num Events
      21
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      12
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      9
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Flu like symptoms
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    INR increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Investigations - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      5
      num Events
      29
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
      num Events
      11
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Neutrophil count decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      7
    term
    White blood cell decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypophosphatemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Eye disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypophosphatemia
time Frame
5 years

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