Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00714259 · ADVERSE EVENTS

Adverse events

Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies · Source last updated 2017-07-24

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Single Arm Trial

Single Arm Intervention trial as noted in interventions section Fludarabine: Fludarabine 30 mg/m2/day x 3 days Total Body Irradiation: TBI 200cGy x1 dose on transplant day Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.

3 / 50 / 5Not reported / Not reported

Group identifiers: EG000: Single Arm Trial

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    RSV pneumonia Infection
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Klebsiella pneumonia Infection
  3. notes
    Pneumonia not otherwise specified
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Pneumonia

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
      Single Arm Intervention trial as noted in interventions section Fludarabine: Fludarabine 30 mg/m2/day x 3 days Total Body Irradiation: TBI 200cGy x1 dose on transplant day Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\*6 CD34+ cells per kilogram of recipient weight.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      5
      serious Num Affected
      3
      serious Num At Risk
      5
      title
      Single Arm Trial
    frequency Threshold
    0
    serious Events
    1. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      RSV pneumonia Infection
    2. organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Klebsiella pneumonia Infection
    3. notes
      Pneumonia not otherwise specified
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      Pneumonia

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

    Preserved source evidence · Not medical advice