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NCT01568866 · ADVERSE EVENTS

Adverse events

Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients · Source last updated 2022-11-14

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 drug up to 30 days after the last dose of study drug as of the data cut-off date of 03 January 2017; median duration of treatment was 27 weeks in the bortezomib group and 48 weeks in the carfilzomib treatment group.
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
Bortezomib

Not reported

182 / 456435 / 456Not reported / Not reported
Carfilzomib

Not reported

272 / 463446 / 463Not reported / Not reported

Group identifiers: EG000: Bortezomib · EG001: Carfilzomib

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 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      463
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      463
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    HAEMORRHAGIC ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    PLASMACYTOSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      463
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      463
    term
    THROMBOTIC MICROANGIOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    THROMBOTIC THROMBOCYTOPENIC PURPURA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      463
    term
    ACUTE CORONARY SYNDROME
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    ACUTE LEFT VENTRICULAR FAILURE
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      463
    term
    ANGINA PECTORIS

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 15.1
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      196
      num At Risk
      463
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      463
    term
    LYMPHOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      463
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      463
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      463
    term
    CATARACT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      463
    term
    CONJUNCTIVITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      463
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      463
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      463
    term
    ABDOMINAL PAIN UPPER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      463
    term
    CONSTIPATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      167
      num At Risk
      463
    term
    DIARRHOEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      463
    term
    DYSPEPSIA
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. id
    EG000
    other Num Affected
    435
    other Num At Risk
    456
    serious Num Affected
    182
    serious Num At Risk
    456
    title
    Bortezomib
  2. id
    EG001
    other Num Affected
    446
    other Num At Risk
    463
    serious Num Affected
    272
    serious Num At Risk
    463
    title
    Carfilzomib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      196
      num At Risk
      463
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      463
    term
    LYMPHOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      463
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      463
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      463
    term
    CATARACT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      463
    term
    CONJUNCTIVITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      463
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      463
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      463
    term
    ABDOMINAL PAIN UPPER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      463
    term
    CONSTIPATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      184
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      167
      num At Risk
      463
    term
    DIARRHOEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      463
    term
    DYSPEPSIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      463
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      463
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    HAEMORRHAGIC ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    PLASMACYTOSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      463
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      463
    term
    THROMBOTIC MICROANGIOPATHY
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    THROMBOTIC THROMBOCYTOPENIC PURPURA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      463
    term
    ACUTE CORONARY SYNDROME
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    ACUTE LEFT VENTRICULAR FAILURE
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      463
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      463
    term
    ANGINA PECTORIS
time Frame
From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 03 January 2017; median duration of treatment was 27 weeks in the bortezomib group and 48 weeks in the carfilzomib treatment group.

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