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NCT00860574 · ADVERSE EVENTS

Adverse events

Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia · Source last updated 2021-06-22

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
Toxicities Before Day 100
Other-event reporting threshold
0%

Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Allogeneic Transplantation)

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV

17 / 9668 / 9621 / 96

Group identifiers: EG000: Treatment (Allogeneic Transplantation)

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      96
    term
    Mucositis
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Bacterial/sepsis
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Heart failure
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Gut GVHD
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      96
    term
    Sepsis
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    VRE bacteremia/sepsis
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Disseminated toxoplasmosis
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Enterococcal bacteremia/VRE
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    CMV pneumonia
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Aspirgillus
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Hypotension
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Hyperglycemia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      96
    term
    Mucositis
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Mucosi
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      96
    term
    Infections
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Deep vein thrombosis
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      96
    term
    Fatigue
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Adrenal insufficiency
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      96
    term
    Hyperglycemia
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Retinal central vein occlusion
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Dehydration
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Proximal myopathy
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Steroid induced DM
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    LE weakness/deconditioning
Complete source fields
description
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    96
    description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV
    id
    EG000
    other Num Affected
    68
    other Num At Risk
    96
    serious Num Affected
    17
    serious Num At Risk
    96
    title
    Treatment (Allogeneic Transplantation)
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      96
    term
    Mucositis
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Mucosi
  3. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      96
    term
    Infections
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Deep vein thrombosis
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      96
    term
    Fatigue
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Adrenal insufficiency
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      96
    term
    Hyperglycemia
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Retinal central vein occlusion
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Dehydration
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Proximal myopathy
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Steroid induced DM
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    LE weakness/deconditioning
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      96
    term
    Mucositis
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Bacterial/sepsis
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Heart failure
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Gut GVHD
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      96
    term
    Sepsis
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    VRE bacteremia/sepsis
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Disseminated toxoplasmosis
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Enterococcal bacteremia/VRE
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    CMV pneumonia
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Aspirgillus
  11. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
    term
    Hypotension
  12. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
    term
    Hyperglycemia
time Frame
Toxicities Before Day 100

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

Preserved source evidence · Not medical advice