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NCT00322101 · ADVERSE EVENTS

Adverse events

Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia · Source last updated 2014-10-31

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
Arm I (Nonmyeloablative Regimen)

CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.

3 / 1212 / 12Not reported / Not reported
Arm II (Myeloablative Regimen)

CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

4 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: Arm I (Nonmyeloablative Regimen) · EG001: Arm II (Myeloablative Regimen)

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    severe diarrhea due to gut GVHD
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    tachycardia and hypotenstion
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombotic Microangiopathy
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Mucositis
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      12
      num Events
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    Infection
Complete source fields
event Groups
  1. description
    CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Arm I (Nonmyeloablative Regimen)
  2. description
    CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Arm II (Myeloablative Regimen)
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      11
      num Events
      6
    term
    Mucositis
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      12
      num Events
      12
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      5
    term
    Infection
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    severe diarrhea due to gut GVHD
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    tachycardia and hypotenstion
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombotic Microangiopathy
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis

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Preserved source evidence · Not medical advice