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NCT00112593 · ADVERSE EVENTS

Adverse events

Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer · Source last updated 2017-05-24

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
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)

CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies

0 / 50 / 5Not reported / Not reported

Group identifiers: EG000: Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)

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.

      Complete source fields
      event Groups
      1. description
        CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation cyclosporine: Given IV or PO mycophenolate mofetil: Given IV or PO laboratory biomarker analysis: Correlative studies
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        5
        serious Num Affected
        0
        serious Num At Risk
        5
        title
        Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)
      frequency Threshold
      5

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

      Preserved source evidence · Not medical advice