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NCT00477971 · ADVERSE EVENTS

Adverse events

Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2016-05-17

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Low-Dose Melphalan

Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)

6 / 3434 / 34Not reported / Not reported
High-Dose Melphalan + Autologous HSC

Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.

3 / 5555 / 55Not reported / Not reported

Group identifiers: EG000: Low-Dose Melphalan · EG001: High-Dose Melphalan + Autologous HSC

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
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Myocardial ischemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Ventricular fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Upper gastrointestinal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Disease progression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Sudden death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sepsis

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 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      55
      num Events
      33
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      34
      num Events
      41
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      55
      num Events
      63
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      7
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      3
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Sinus tachycardia
Complete source fields
event Groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    6
    serious Num At Risk
    34
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    55
    serious Num Affected
    3
    serious Num At Risk
    55
    title
    High-Dose Melphalan + Autologous HSC
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      55
      num Events
      33
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      34
      num Events
      41
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      55
      num Events
      63
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Arrhythmia supraventricular
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      55
      num Events
      7
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      3
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Sinus tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Myocardial ischemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pericardial effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Ventricular fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Upper gastrointestinal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Disease progression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Sudden death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      34
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Hepatic failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sepsis

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