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NCT01812252 · ADVERSE EVENTS

Adverse events

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15

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
All-Cause Mortality was assessed up to 18 months from start of treatment.
Other-event reporting threshold
0%

Serious AEs and Other AEs were not collected for this study. Only All-Cause Mortality was monitored.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Decitabine or Azacitidine)

Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies

0 / 00 / 016 / 25
Arm B (Induction-like Chemotherapy Regimen)

Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies

0 / 00 / 014 / 25

Group identifiers: EG000: Arm A (Decitabine or Azacitidine) · EG001: Arm B (Induction-like Chemotherapy Regimen)

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
      description
      Serious AEs and Other AEs were not collected for this study. Only All-Cause Mortality was monitored.
      event Groups
      1. deaths Num Affected
        16
        deaths Num At Risk
        25
        description
        Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Azacitidine (AZC): Given IV or SC Decitabine: Given IV or SC Quality-of-Life Assessment: Ancillary studies
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Arm A (Decitabine or Azacitidine)
      2. deaths Num Affected
        14
        deaths Num At Risk
        25
        description
        Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only. Quality-of-Life Assessment: Ancillary studies
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Arm B (Induction-like Chemotherapy Regimen)
      frequency Threshold
      0
      time Frame
      All-Cause Mortality was assessed up to 18 months from start of treatment.

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

      Preserved source evidence · Not medical advice