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NCT02002598 · ADVERSE EVENTS

Adverse events

Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma · Source last updated 2024-09-19

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
Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Other-event reporting threshold
0%

Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CFZ With Bendamustine and Dexamethasone

First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg. Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.

7 / 2020 / 202 / 20

Group identifiers: EG000: CFZ With Bendamustine and Dexamethasone

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Gastrointestinal disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    General disorders and administration site conditions
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Infections and infestations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Respiratory, thoracic and mediastinal disorder

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Anal hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Bloating
Complete source fields
description
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    20
    description
    First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg. Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    7
    serious Num At Risk
    20
    title
    CFZ With Bendamustine and Dexamethasone
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Alkaline phosphatase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Anal hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      20
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Anxiety
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Bloating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Gastrointestinal disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    General disorders and administration site conditions
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
    term
    Infections and infestations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Respiratory, thoracic and mediastinal disorder
time Frame
Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.

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Preserved source evidence · Not medical advice