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NCT01818752 · ADVERSE EVENTS

Adverse events

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma · Source last updated 2019-08-26

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 any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
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, Melphalan, Prednisone

Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

198 / 470437 / 470Not reported / Not reported
Carfilzomib, Melphalan, Prednisone

Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².

235 / 474437 / 474Not reported / Not reported

Group identifiers: EG000: Bortezomib, Melphalan, Prednisone · EG001: Carfilzomib, Melphalan, Prednisone

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 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      474
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Haemolytic uraemic syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      474
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      474
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Aortic valve incompetence

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 19.0
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      474
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      474
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      474
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      474
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      474
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      474
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      474
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      474
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      474
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      167
      num At Risk
      474
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      474
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      474
    term
    Asthenia
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 received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    EG000
    other Num Affected
    437
    other Num At Risk
    470
    serious Num Affected
    198
    serious Num At Risk
    470
    title
    Bortezomib, Melphalan, Prednisone
  2. description
    Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
    id
    EG001
    other Num Affected
    437
    other Num At Risk
    474
    serious Num Affected
    235
    serious Num At Risk
    474
    title
    Carfilzomib, Melphalan, Prednisone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      143
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      168
      num At Risk
      474
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      474
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      474
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      474
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      474
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      474
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      474
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      474
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      474
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      167
      num At Risk
      474
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      474
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      474
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      474
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      474
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Haemolytic uraemic syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      474
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      474
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      474
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      470
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      474
    term
    Aortic valve incompetence
time Frame
From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.

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