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NCT01903811 · ADVERSE EVENTS

Adverse events

S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma · Source last updated 2024-12-20

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
For the duration of treatment, up to 12 cycles and maximum follow up of 3 years post-registration.
Other-event reporting threshold
5%

Note that denominators differ from those reported in other Results sections as the AE data tables are pulled from the live database and thus reflect more current data while other Sections are based those data reported at the time of Primary Endpoint analyses.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Dexamethasone, Low-dose Carfilzomib)

Patients receive dexamethasone and low dose carfilzomib. Includes all eligible and analyzable patients. Deaths for patients that registered Crossover arm are also counted in this arm.

26 / 6666 / 6638 / 66
Arm II (Dexamethasone, High-dose Carfilzomib)

Patients receive dexamethasone and high dose carfilzomib. Includes all eligible and analyzable patients.

27 / 5755 / 5740 / 57
Crossover Arm

Patients on Arm 1 that progress after the start of cycle 2 and prior to completion of 12 cycles receive high dose carfilzomib. Includes all eligible and analyzable patients. These patients are also included under "Arm I".

5 / 1614 / 1612 / 16

Group identifiers: EG000: Arm I (Dexamethasone, Low-dose Carfilzomib) · EG001: Arm II (Dexamethasone, High-dose Carfilzomib) · EG002: Crossover Arm

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
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Restrictive cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Blurred vision

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
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Cardiac disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Hearing impaired
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Blurred vision
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Watering eyes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Bloating
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    term
    Diarrhea
Complete source fields
description
Note that denominators differ from those reported in other Results sections as the AE data tables are pulled from the live database and thus reflect more current data while other Sections are based those data reported at the time of Primary Endpoint analyses.
event Groups
  1. deaths Num Affected
    38
    deaths Num At Risk
    66
    description
    Patients receive dexamethasone and low dose carfilzomib. Includes all eligible and analyzable patients. Deaths for patients that registered Crossover arm are also counted in this arm.
    id
    EG000
    other Num Affected
    66
    other Num At Risk
    66
    serious Num Affected
    26
    serious Num At Risk
    66
    title
    Arm I (Dexamethasone, Low-dose Carfilzomib)
  2. deaths Num Affected
    40
    deaths Num At Risk
    57
    description
    Patients receive dexamethasone and high dose carfilzomib. Includes all eligible and analyzable patients.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    57
    serious Num Affected
    27
    serious Num At Risk
    57
    title
    Arm II (Dexamethasone, High-dose Carfilzomib)
  3. deaths Num Affected
    12
    deaths Num At Risk
    16
    description
    Patients on Arm 1 that progress after the start of cycle 2 and prior to completion of 12 cycles receive high dose carfilzomib. Includes all eligible and analyzable patients. These patients are also included under "Arm I".
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    16
    serious Num Affected
    5
    serious Num At Risk
    16
    title
    Crossover Arm
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Cardiac disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Hearing impaired
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Blurred vision
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Watering eyes
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Bloating
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Restrictive cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Sinus tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    term
    Supraventricular tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    term
    Blurred vision
time Frame
For the duration of treatment, up to 12 cycles and maximum follow up of 3 years post-registration.

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