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NCT00084747 · ADVERSE EVENTS

Adverse events

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma · Source last updated 2020-08-17

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
Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib

bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities

2 / 3019 / 30Not reported / Not reported

Group identifiers: EG000: Bortezomib

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Nausea/Dehydration
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Pneumonia

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      19
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Anorexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Dyspepsia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      9
    term
    nausea/vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      7
    term
    Diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
      num Events
      4
    term
    Cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Upper Respiratory Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      11
    term
    Neuropathy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      30
      num Events
      17
    term
    Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Peripheral Edema
Complete source fields
event Groups
  1. description
    bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    30
    serious Num Affected
    2
    serious Num At Risk
    30
    title
    Bortezomib
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      19
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Fever
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Anorexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Dyspepsia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      9
    term
    nausea/vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      7
    term
    Diarrhea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      30
      num Events
      3
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
      num Events
      4
    term
    Cough
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Upper Respiratory Infection
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      11
    term
    Neuropathy
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      30
      num Events
      17
    term
    Pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Peripheral Edema
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Nausea/Dehydration
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Pneumonia
time Frame
Adverse event information was collected from the time subject signed consent until 30 days post last treatment up to 2 years.

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Preserved source evidence · Not medical advice