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NCT00579111 · ADVERSE EVENTS

Adverse events

Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB) · Source last updated 2016-05-04

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
HLA-identical Sibling Transplant

Recipients of HLA identical sibling stem cell transplants

2 / 30 / 3Not reported / Not reported
Unrelated Matched or Single Antigen Mismatched Transplant

Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants

0 / 10 / 1Not reported / Not reported

Group identifiers: EG000: HLA-identical Sibling Transplant · EG001: Unrelated Matched or Single Antigen Mismatched 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Blood/Bone Marrow - Other: Engraftment Failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e

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
      Recipients of HLA identical sibling stem cell transplants
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      3
      serious Num Affected
      2
      serious Num At Risk
      3
      title
      HLA-identical Sibling Transplant
    2. description
      Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Unrelated Matched or Single Antigen Mismatched Transplant
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
        num Events
        0
      term
      Blood/Bone Marrow - Other: Engraftment Failure
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
        num Events
        0
      term
      Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e

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

    Preserved source evidence · Not medical advice