Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00003270 · ADVERSE EVENTS

Adverse events

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer · Source last updated 2019-12-13

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 Event, Serious Adverse Event and All Cause Mortality are from start of treatment (Day -7 or -5) through day +100 after cord blood infusion
Other-event reporting threshold
5%

SAE is delayed engraftment or failed to engraft Died before engraftment is defined as death before Absolute Neutrophil Count recovery Failure to engraft is defined as survival until at least day +42 without Absolute Neutrophil Count recovery Other AEs include acute GVHD grade III-IV and RRT grade 3-4 RRT is defined using Bearman Regimen Related Toxicity Criteria Acute GVHD grade III-IV is defined using Glucksberg criteria

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1

Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0

5 / 205 / 208 / 20

Group identifiers: EG000: Arm 1

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
    notes
    DBE: Died before engraftment (did not achieve absolute neutrophil recovery) FTE: Failed to engraft (survived to at least day +42 without absolute neutrophil recovery
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    term
    DBE/FTE

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
    notes
    Overall grade III-IV acute graft-versus-host disease
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    term
    Severe Acute graft-versus-host disease
Complete source fields
description
SAE is delayed engraftment or failed to engraft Died before engraftment is defined as death before Absolute Neutrophil Count recovery Failure to engraft is defined as survival until at least day +42 without Absolute Neutrophil Count recovery Other AEs include acute GVHD grade III-IV and RRT grade 3-4 RRT is defined using Bearman Regimen Related Toxicity Criteria Acute GVHD grade III-IV is defined using Glucksberg criteria
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    20
    description
    Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    20
    serious Num Affected
    5
    serious Num At Risk
    20
    title
    Arm 1
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Overall grade III-IV acute graft-versus-host disease
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    term
    Severe Acute graft-versus-host disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DBE: Died before engraftment (did not achieve absolute neutrophil recovery) FTE: Failed to engraft (survived to at least day +42 without absolute neutrophil recovery
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
      num Events
      5
    term
    DBE/FTE
time Frame
Adverse Event, Serious Adverse Event and All Cause Mortality are from start of treatment (Day -7 or -5) through day +100 after cord blood infusion

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

Preserved source evidence · Not medical advice