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NCT01204788 · ADVERSE EVENTS

Adverse events

Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia · Source last updated 2015-06-10

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
Adverse events collected for up to two cycles of anti-leukemia treatment. Overall study period: June 16, 2011 to August 30, 2012.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1 (Prophylactic Arm)

Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops

0 / 10 / 1Not reported / Not reported
Arm 2 (Therapeutic Arm)

Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)

0 / 30 / 3Not reported / Not reported

Group identifiers: EG000: Arm 1 (Prophylactic Arm) · EG001: Arm 2 (Therapeutic Arm)

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
        Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        1
        serious Num Affected
        0
        serious Num At Risk
        1
        title
        Arm 1 (Prophylactic Arm)
      2. description
        Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        3
        serious Num Affected
        0
        serious Num At Risk
        3
        title
        Arm 2 (Therapeutic Arm)
      frequency Threshold
      5
      time Frame
      Adverse events collected for up to two cycles of anti-leukemia treatment. Overall study period: June 16, 2011 to August 30, 2012.

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

      Preserved source evidence · Not medical advice