Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04756401 · ADVERSE EVENTS

Adverse events

Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma · Source last updated 2026-09-15

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 (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)

Selinexor: Given PO

4 / 87 / 80 / 8

Group identifiers: EG000: Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)

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
      1
      num At Risk
      8
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Infections and infestations - Oth spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    term
    Upper respiratory infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pneumonitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Skin and subcut tissue disord - 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 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
      num Events
      6
    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
      8
      num Events
      1
    term
    Blurred vision
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      13
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      10
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      8
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      16
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Infections and infestations - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lung infection
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Selinexor: Given PO
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Treatment (Carfilzomib, Daratumumab, Dexamethasone, Selinexor)
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
      3
      num At Risk
      8
      num Events
      6
    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
      8
      num Events
      1
    term
    Blurred vision
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      13
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Gastrointestinal disorders - Oth spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      10
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      8
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      16
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Infections and infestations - Oth spec
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lung infection
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
      1
      num At Risk
      8
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Infections and infestations - Oth spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      3
    term
    Upper respiratory infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Infusion related reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Pneumonitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Skin and subcut tissue disord - Oth spec
time Frame
2 years

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice