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NCT03506360 · ADVERSE EVENTS

Adverse events

Pembrolizumab, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-01-09

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
2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)

Patients receive ixazomib citrate PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71 and pembrolizumab IV over 30 minutes on days 1, 22, 43, 64. Patients also receive dexamethasone PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71. Cycles with dexamethasone repeat every 84 days for up to 1 year and cycles with ixazomib citrate and pembrolizumab repeat every 84 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

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Group identifiers: EG000: Treatment (Ixazomib Citrate, Pembrolizumab, and 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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec

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
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      19
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      10
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      10
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      13
      num Events
      40
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
      num Events
      22
    term
    Creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      19
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Lymphocyte count increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      4
    term
    Neutrophil count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      13
      num Events
      32
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    White blood cell decreased
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    13
    description
    Patients receive ixazomib citrate PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71 and pembrolizumab IV over 30 minutes on days 1, 22, 43, 64. Patients also receive dexamethasone PO on days 1, 8, 15, 29, 36, 43, 57, 64, and 71. Cycles with dexamethasone repeat every 84 days for up to 1 year and cycles with ixazomib citrate and pembrolizumab repeat every 84 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    1
    serious Num At Risk
    13
    title
    Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      9
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      19
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      10
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      10
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      13
      num Events
      40
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
      num Events
      22
    term
    Creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      19
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Lymphocyte count increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      4
    term
    Neutrophil count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      13
      num Events
      32
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    White blood cell decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec
time Frame
2 years

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Preserved source evidence · Not medical advice