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NCT01605032 · ADVERSE EVENTS

Adverse events

Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2020-08-20

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
Up to 2 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)

CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT

1 / 1919 / 191 / 19

Group identifiers: EG000: Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    term
    Death - 70 days after the autologous stem cell transplant

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
    notes
    Grade 3 \& 4
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    term
    Electrolyte abnormalities
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      19
    term
    Oral mucositis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    term
    Dysphagia/Odynophagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      19
    term
    Transaminitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      19
    term
    Nausea and/or vomitting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      19
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    term
    Fever without neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      19
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, 4 \& 5
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      19
    term
    Infections
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    term
    Noninfectious pulmonary toxicity
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    19
    description
    CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    1
    serious Num At Risk
    19
    title
    Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    term
    Electrolyte abnormalities
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      19
    term
    Oral mucositis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      19
    term
    Dysphagia/Odynophagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      19
    term
    Transaminitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      19
    term
    Nausea and/or vomitting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      19
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
    term
    Fever without neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      19
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, 4 \& 5
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      19
    term
    Infections
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 \& 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
    term
    Noninfectious pulmonary toxicity
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
    term
    Death - 70 days after the autologous stem cell transplant
time Frame
Up to 2 years

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Preserved source evidence · Not medical advice