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NCT00511238 · ADVERSE EVENTS

Adverse events

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma · Source last updated 2017-08-31

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 adverse events (AEs) should be reported from the time the subject signs consent through 30 days post-last dose of study drug or initiation of a new anti-cancer therapy, whichever occurs first.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Carfilzomib (A0)

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle

20 / 4646 / 46Not reported / Not reported
Carfilzomib (A1)

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.

126 / 266266 / 266Not reported / Not reported

Group identifiers: EG000: Carfilzomib (A0) · EG001: Carfilzomib (A1)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      266
    term
    Cardiac failure congestive
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Cardiac failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Cardiomyopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      266
    term
    Myocardial ischaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Supraventricular tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      266
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Multi-organ failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      266
    term
    Non-cardiac chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      266
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      266
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    term
    Bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Clostridium colitis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      266
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      266
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      266
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      266
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      266
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      266
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      266
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      266
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      266
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      266
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      266
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      266
    term
    Fatigue
Complete source fields
event Groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    46
    serious Num Affected
    20
    serious Num At Risk
    46
    title
    Carfilzomib (A0)
  2. description
    In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
    id
    EG001
    other Num Affected
    266
    other Num At Risk
    266
    serious Num Affected
    126
    serious Num At Risk
    266
    title
    Carfilzomib (A1)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      266
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      103
      num At Risk
      266
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      266
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      266
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      266
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      266
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      266
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      266
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      266
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      266
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      266
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      266
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      266
    term
    Cardiac failure congestive
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Cardiac failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Cardiomyopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      266
    term
    Myocardial ischaemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Supraventricular tachycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      266
    term
    Disease progression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Multi-organ failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      266
    term
    Non-cardiac chest pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      266
    term
    Pyrexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      266
    term
    Pneumonia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
    term
    Bacteraemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (8.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
    term
    Clostridium colitis
time Frame
All adverse events (AEs) should be reported from the time the subject signs consent through 30 days post-last dose of study drug or initiation of a new anti-cancer therapy, whichever occurs first.

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