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NCT00530816 · ADVERSE EVENTS

Adverse events

Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma · Source last updated 2017-05-02

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
From the first dose of study medication until 30 days after the last dose or initiation of new, non-protocol therapy for MM, whichever was first; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.
Other-event reporting threshold
5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Carfilzomib 20 mg/m²

Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.

12 / 3535 / 35Not reported / Not reported
Part 2: Carfilzomib 20 mg/m²

Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.

18 / 5959 / 59Not reported / Not reported
Part 2: Carfilzomib 20/27 mg/m²

Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.

27 / 7070 / 70Not reported / Not reported

Group identifiers: EG000: Part 1: Carfilzomib 20 mg/m² · EG001: Part 2: Carfilzomib 20 mg/m² · EG002: Part 2: Carfilzomib 20/27 mg/m²

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 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Mitral valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Hyperthyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain

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 8.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      70
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      70
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      70
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Diplopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Eye irritation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Lacrimation increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Vision blurred
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. description
    Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    EG000
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    12
    serious Num At Risk
    35
    title
    Part 1: Carfilzomib 20 mg/m²
  2. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
    id
    EG001
    other Num Affected
    59
    other Num At Risk
    59
    serious Num Affected
    18
    serious Num At Risk
    59
    title
    Part 2: Carfilzomib 20 mg/m²
  3. description
    Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
    id
    EG002
    other Num Affected
    70
    other Num At Risk
    70
    serious Num Affected
    27
    serious Num At Risk
    70
    title
    Part 2: Carfilzomib 20/27 mg/m²
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      70
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      70
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      70
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Diplopia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      70
    term
    Eye irritation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Lacrimation increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      70
    term
    Vision blurred
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      70
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      70
    term
    Cardiac failure congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Mitral valve incompetence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Hyperthyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 8.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain
time Frame
From the first dose of study medication until 30 days after the last dose or initiation of new, non-protocol therapy for MM, whichever was first; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.

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Preserved source evidence · Not medical advice