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NCT03859427 · ADVERSE EVENTS

Adverse events

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-08-13

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 was collected from enrollment to End of Study; median study duration was 12.0 months. AEs were collected from first dose of study drug to last dose of study drug + 30 days; median treatment duration (any study treatment) was 11.8 months.
Other-event reporting threshold
5%

All-cause mortality was collected for all participants enrolled/randomized in the study and is presented according to the randomized treatment arm. Serious AEs and other AEs were collected for all participants in the safety population who received at least one dose of study drug. Participants in the safety population were analyzed according to the treatment arm corresponding to the actual treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Twice-weekly KRd 20/27 mg/m^2

Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

75 / 231190 / 23122 / 226
Once-weekly KRd 20/56 mg/m^2

Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

84 / 223182 / 22326 / 228

Group identifiers: EG000: Twice-weekly KRd 20/27 mg/m^2 · EG001: Once-weekly KRd 20/56 mg/m^2

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      223
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      223
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Thrombotic microangiopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Cardiac failure acute

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      223
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      223
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      223
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      223
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      223
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      223
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      223
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      223
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      223
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      223
    term
    Hepatic function abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      223
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    COVID-19
Complete source fields
description
All-cause mortality was collected for all participants enrolled/randomized in the study and is presented according to the randomized treatment arm. Serious AEs and other AEs were collected for all participants in the safety population who received at least one dose of study drug. Participants in the safety population were analyzed according to the treatment arm corresponding to the actual treatment received.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    226
    description
    Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    EG000
    other Num Affected
    190
    other Num At Risk
    231
    serious Num Affected
    75
    serious Num At Risk
    231
    title
    Twice-weekly KRd 20/27 mg/m^2
  2. deaths Num Affected
    26
    deaths Num At Risk
    228
    description
    Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    EG001
    other Num Affected
    182
    other Num At Risk
    223
    serious Num Affected
    84
    serious Num At Risk
    223
    title
    Once-weekly KRd 20/56 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      223
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      223
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      223
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      223
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      223
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      223
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      223
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      223
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      223
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      223
    term
    Hepatic function abnormal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      223
    term
    Bronchitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      223
    term
    COVID-19
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      223
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      223
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Thrombotic microangiopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
    term
    Cardiac failure acute
time Frame
All-cause mortality was collected from enrollment to End of Study; median study duration was 12.0 months. AEs were collected from first dose of study drug to last dose of study drug + 30 days; median treatment duration (any study treatment) was 11.8 months.

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