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NCT01083316 · ADVERSE EVENTS

Adverse events

Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis · Source last updated 2020-09-25

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
100 days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib and Dexamethasone

Induction: Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days Conditioning: Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1 Bortezomib (Velcade) and Dexamethasone: Induction: Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days Conditioning: Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1

35 / 3535 / 35Not reported / Not reported

Group identifiers: EG000: Bortezomib 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    autograft versus host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    term
    neutropenic fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
    term
    fever
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Acute kidney failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Adult Respiratory Distress Syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    creatinine increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
      num Events
      15
    term
    diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Epstein Barr Virus-related Polymorphous Post Transplant Lymphoproliferative disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    epistaxis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      35
      num Events
      18
    term
    fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    gastrointestinal bleed

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
    organ System
    Investigations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    alkaline phosphatase elevated
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    drug rash
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
      num Events
      15
    term
    nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      14
    term
    diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    adrenal insufficiency
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
      num Events
      13
    term
    constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    anorexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      35
      num Events
      8
    term
    hypotension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      14
    term
    alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    term
    rash
Complete source fields
event Groups
  1. description
    Induction: Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days Conditioning: Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1 Bortezomib (Velcade) and Dexamethasone: Induction: Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days Conditioning: Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1
    id
    EG000
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    35
    serious Num At Risk
    35
    title
    Bortezomib and Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    alkaline phosphatase elevated
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    drug rash
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    tinnitus
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
      num Events
      15
    term
    nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      14
    term
    diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    adrenal insufficiency
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
      num Events
      13
    term
    constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
      num Events
      5
    term
    anorexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      35
      num Events
      4
    term
    abdominal distension
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      35
      num Events
      8
    term
    hypotension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      35
      num Events
      14
    term
    alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    term
    rash
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
      num Events
      2
    term
    autograft versus host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
      num Events
      7
    term
    neutropenic fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      35
    term
    fever
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
      num Events
      3
    term
    Acute kidney failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Adult Respiratory Distress Syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    cardiac arrest
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    creatinine increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
      num Events
      15
    term
    diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    Epstein Barr Virus-related Polymorphous Post Transplant Lymphoproliferative disorder
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    epistaxis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      35
      num Events
      18
    term
    fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
      num Events
      1
    term
    gastrointestinal bleed
time Frame
100 days

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Preserved source evidence · Not medical advice