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NCT01413178 · ADVERSE EVENTS

Adverse events

A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma · Source last updated 2020-04-21

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
From the time of ASCT until 12 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Busulfan + Melphalan

Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant

73 / 104101 / 10423 / 104
Melphalan

High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant

32 / 9898 / 9821 / 98

Group identifiers: EG000: Busulfan + Melphalan · EG001: Melphalan

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated ALT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated Tbili
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      98
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Mucositis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Myocardial ischemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Neuropathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      98
    term
    Neutropenic fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Transient blindness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Nausea

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
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Arrhythmia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Chemo burns
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      98
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dysuria
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Elevated ALT
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Elevated AST
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      98
    term
    Elevated Tbili
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      98
    term
    Fluid overload
Complete source fields
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    104
    description
    Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
    id
    EG000
    other Num Affected
    101
    other Num At Risk
    104
    serious Num Affected
    73
    serious Num At Risk
    104
    title
    Busulfan + Melphalan
  2. deaths Num Affected
    21
    deaths Num At Risk
    98
    description
    High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
    id
    EG001
    other Num Affected
    98
    other Num At Risk
    98
    serious Num Affected
    32
    serious Num At Risk
    98
    title
    Melphalan
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Arrhythmia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Chemo burns
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      98
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Dysuria
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Elevated ALT
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Elevated AST
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      98
    term
    Elevated Tbili
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      98
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      98
    term
    Fluid overload
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      98
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated ALT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Elevated Tbili
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      98
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Mucositis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      98
    term
    Myocardial ischemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Neuropathy
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      98
    term
    Neutropenic fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      98
    term
    Transient blindness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      104
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      98
    term
    Nausea
time Frame
From the time of ASCT until 12 months.

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