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NCT01251575 · ADVERSE EVENTS

Adverse events

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant · Source last updated 2019-12-09

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
AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Fludarabine, Transplant, Immunosuppression)

CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation. IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant Sirolimus: Given PO Total-Body Irradiation: Undergo total-body irradiation

0 / 7625 / 7621 / 76

Group identifiers: EG000: Treatment (Fludarabine, Transplant, Immunosuppression)

Serious adverse events

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

    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
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        76
        num Events
        4
      term
      Acute kidney injury
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Ascites
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Atrial fibrillation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Atrial flutter
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Blood bilirubin increased
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        76
        num Events
        2
      term
      Bronchopulmonary hemorrhage
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        76
        num Events
        2
      term
      Chronic kidney disease
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Creatinine increased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Diarrhea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Ejection fraction decreased
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Encephalitis infection
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        76
        num Events
        4
      term
      Febrile neutropenia
    Complete source fields
    event Groups
    1. deaths Num Affected
      21
      deaths Num At Risk
      76
      description
      CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation. IMMUNOSUPPRESSION: Patients receive sirolimus PO QD on days -3 to 180 with taper to day 365; cyclosporine PO BID on days -3 to 150 with taper to day 180; and mycophenolate mofetil PO TID on days 0-30 and then BID to day 100 with taper to day 150. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant Sirolimus: Given PO Total-Body Irradiation: Undergo total-body irradiation
      id
      EG000
      other Num Affected
      25
      other Num At Risk
      76
      serious Num Affected
      0
      serious Num At Risk
      76
      title
      Treatment (Fludarabine, Transplant, Immunosuppression)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        76
        num Events
        4
      term
      Acute kidney injury
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Ascites
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Atrial fibrillation
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Atrial flutter
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Blood bilirubin increased
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        76
        num Events
        2
      term
      Bronchopulmonary hemorrhage
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        76
        num Events
        2
      term
      Chronic kidney disease
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Creatinine increased
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        76
        num Events
        3
      term
      Diarrhea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Ejection fraction decreased
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        76
        num Events
        1
      term
      Encephalitis infection
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        76
        num Events
        4
      term
      Febrile neutropenia
    time Frame
    AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice