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NCT00445744 · ADVERSE EVENTS

Adverse events

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome · Source last updated 2018-01-02

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 3 years after enrollment
Other-event reporting threshold
5%

Causes of death were recorded as adverse events. Other adverse events were not recorded in this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Cyclophosphamide, Busulfan, Transplant)

CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation

19 / 520 / 019 / 52

Group identifiers: EG000: Treatment (Cyclophosphamide, Busulfan, Transplant)

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    graft-versus-host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      52
    term
    Recurrent or progressive malignancy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
    term
    Infection associated with graft-versus-host disease
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
    term
    infection not associated with graft-versus-host disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    Secondary malignancy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
    term
    suicide

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
    description
    Causes of death were recorded as adverse events. Other adverse events were not recorded in this study.
    event Groups
    1. deaths Num Affected
      19
      deaths Num At Risk
      52
      description
      CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      19
      serious Num At Risk
      52
      title
      Treatment (Cyclophosphamide, Busulfan, Transplant)
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        52
      term
      graft-versus-host disease
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        52
      term
      Recurrent or progressive malignancy
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        52
      term
      Infection associated with graft-versus-host disease
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        52
      term
      infection not associated with graft-versus-host disease
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        52
      term
      Secondary malignancy
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        52
      term
      suicide
    time Frame
    Up to 3 years after enrollment

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

    Preserved source evidence · Not medical advice