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NCT04191616 · ADVERSE EVENTS

Adverse events

Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet · Source last updated 2025-09-04

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
All-cause mortality: from enrollment until the end of study or death date, whichever occurs later; Median (min, max) time on study was 15.2 (0.0, 47.0) months. Adverse events: from the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occurs earlier; Median (min, max) was 8.5 (1.0, 46.6) months
Other-event reporting threshold
5%

All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carfilzomib With Pomalidomide and Dexamethasone (KPd)

Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.

22 / 5248 / 5237 / 54

Group identifiers: EG000: Carfilzomib With Pomalidomide and Dexamethasone (KPd)

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac failure chronic
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Left ventricular failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    COVID-19 pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Clostridium difficile infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cytomegalovirus 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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      52
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      52
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      52
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    COVID-19
Complete source fields
description
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    37
    deaths Num At Risk
    54
    description
    Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    52
    serious Num Affected
    22
    serious Num At Risk
    52
    title
    Carfilzomib With Pomalidomide and Dexamethasone (KPd)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      52
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      52
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      52
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      52
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      52
    term
    Oedema peripheral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      52
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
    term
    COVID-19
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cardiac failure chronic
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Left ventricular failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    COVID-19 pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Clostridium difficile infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Cytomegalovirus infection
time Frame
All-cause mortality: from enrollment until the end of study or death date, whichever occurs later; Median (min, max) time on study was 15.2 (0.0, 47.0) months. Adverse events: from the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occurs earlier; Median (min, max) was 8.5 (1.0, 46.6) months

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