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NCT01222260 · ADVERSE EVENTS

Adverse events

Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis · Source last updated 2020-03-30

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
2 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Arm

Subjects with AL will receive Bendamustine and Dexamethasone Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle: * CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle * CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle Available to qualifying subjects is the option to dose escalate to dose level (+)1: * 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study) * 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study) Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle

10 / 2920 / 291 / 29

Group identifiers: EG000: Treatment 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Renal dysfunction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Rash
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Infusion-related reaction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Fever and chills
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Atrial fibrillation

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
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
      num Events
      8
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      6
    term
    Decreased lymphocyte count
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
      num Events
      4
    term
    Chronic kidney disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Hypotension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Decreased neutrophil count
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Syncope
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Decreased white blood cell count
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Anemia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    29
    description
    Subjects with AL will receive Bendamustine and Dexamethasone Bendamustine: Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle: * CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle * CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle Available to qualifying subjects is the option to dose escalate to dose level (+)1: * 120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study) * 100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study) Dexamethasone: 40 mg orally on days 1, 8, 15, 22 of each cycle
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    29
    serious Num Affected
    10
    serious Num At Risk
    29
    title
    Treatment Arm
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
      num Events
      8
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
      num Events
      6
    term
    Decreased lymphocyte count
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
      num Events
      4
    term
    Chronic kidney disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Hypotension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Hypertension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Decreased neutrophil count
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
      num Events
      3
    term
    Syncope
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Decreased white blood cell count
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Anemia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Renal dysfunction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Rash
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Infusion-related reaction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Fever and chills
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Atrial fibrillation
time Frame
2 years

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Preserved source evidence · Not medical advice