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NCT00025662 · ADVERSE EVENTS

Adverse events

Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS · Source last updated 2016-10-28

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
The adverse event reporting was collected for 7 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants

Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults

22 / 220 / 22Not reported / Not reported

Group identifiers: EG000: RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants

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
      8
      num At Risk
      8
      num Events
      8
    term
    Non relapse deaths
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      10
      num Events
      10
    term
    Relapse deaths
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      4
    term
    Hospitalization

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
      Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      22
      serious Num Affected
      22
      serious Num At Risk
      22
      title
      RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        8
        num Events
        8
      term
      Non relapse deaths
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        10
        num Events
        10
      term
      Relapse deaths
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
        num Events
        4
      term
      Hospitalization
    time Frame
    The adverse event reporting was collected for 7 years.

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

    Preserved source evidence · Not medical advice