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NCT00943319 · ADVERSE EVENTS

Adverse events

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies · Source last updated 2019-02-04

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
10 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Busulfan and Fludarabine

Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated).

1 / 491 / 4945 / 49

Group identifiers: EG000: Busulfan and Fludarabine

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
      49
      num Events
      1
    term
    Sepsis

Other reported 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
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Mental Status change
Complete source fields
event Groups
  1. deaths Num Affected
    45
    deaths Num At Risk
    49
    description
    Intravenous busulfan (Busulfan®) in combination with fludarabine Busulfan: Daily intravenous dosing to target AVC Fludarabine: Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose. Campath: All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times). Stem Cell Transplant: Infusion of bone marrow and donors(related/ unrelated).
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    49
    serious Num Affected
    1
    serious Num At Risk
    49
    title
    Busulfan and Fludarabine
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Mental Status change
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
      49
      num Events
      1
    term
    Sepsis
time Frame
10 years

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

Preserved source evidence · Not medical advice