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NCT00615589 · ADVERSE EVENTS

Adverse events

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen · Source last updated 2016-04-04

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Flu-Bu4

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.

13 / 2220 / 22Not reported / Not reported

Group identifiers: EG000: Flu-Bu4

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Allergy/Immunology - Other
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Blood/Bone Marrow - Other
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Cardiac General - Other
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Hypotension
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Death, disease progression
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Rash/desquamation
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Diarrhea
  9. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Hemorrhage, bladder
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Febrile neutropenia
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection with Grade 3 or 4 neutrophils
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection - Other

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Blood/Bone Marrow - Other
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Platelets
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Sinus bradycardia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      22
      num Events
      9
    term
    Sinus tachycardia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Supraventricular extrasystoles
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Hypertension
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      6
    term
    Hypotension
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      22
      num Events
      5
    term
    Fatigue (asthenia, lethargy, malaise)
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever
  10. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Insomnia
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Weight gain
  12. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      8
    term
    Dermatology/Skin - Other
Complete source fields
event Groups
  1. description
    Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    22
    serious Num Affected
    13
    serious Num At Risk
    22
    title
    Flu-Bu4
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Blood/Bone Marrow - Other
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Platelets
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Sinus bradycardia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      22
      num Events
      9
    term
    Sinus tachycardia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Supraventricular extrasystoles
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Hypertension
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      6
    term
    Hypotension
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      22
      num Events
      5
    term
    Fatigue (asthenia, lethargy, malaise)
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever
  10. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Insomnia
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Weight gain
  12. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      22
      num Events
      8
    term
    Dermatology/Skin - Other
serious Events
  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Allergy/Immunology - Other
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Blood/Bone Marrow - Other
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Cardiac General - Other
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Hypotension
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Fever
  6. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Death, disease progression
  7. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Rash/desquamation
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Diarrhea
  9. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Hemorrhage, bladder
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Febrile neutropenia
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection with Grade 3 or 4 neutrophils
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Infection - Other

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Preserved source evidence · Not medical advice