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NCT00382109 · ADVERSE EVENTS

Adverse events

Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission · Source last updated 2019-08-07

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%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen

Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \& -4) \& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.

9 / 7238 / 72Not reported / Not reported
Tacro-MTX GVHD Prophylaxis

Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \& -4) \& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).

5 / 7030 / 70Not reported / Not reported

Group identifiers: EG000: Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen · EG001: Tacro-MTX GVHD Prophylaxis

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Acute kidney injury
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Adult respiratory distress syndrome
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Ascites
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Blood bilirubin increased
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Bronchopulmonary hemorrhage
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Cardiac disorders - Other, specify
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Death NOS
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Disseminated intravascular coagulation
  9. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Encephalopathy
  10. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Hepatic failure
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Hepatobiliary disorders - Other, specify
  12. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Hypotension

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
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Acute kidney injury
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Adult respiratory distress syndrome
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Alanine aminotransferase increased
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Anal pain
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Anaphylaxis
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      70
    term
    Anemia
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Ascites
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Aspartate aminotransferase increased
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Ataxia
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Atelectasis
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Bladder infection
Complete source fields
description
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). This study did not collect information about grade 1 and 2 AEs. The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. 4 experimental patients were excluded (2 ineligible, 2 no data).
event Groups
  1. description
    Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \& -4) \& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    72
    serious Num Affected
    9
    serious Num At Risk
    72
    title
    Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen
  2. description
    Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, \& -6, Thiotepa IV (dose 5 mg/kg/day on days -5 \& -4) \& cyclophosphamide IV (dose 60 mg/kg/day on days -3 \& -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, \& 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, \& 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
    id
    EG001
    other Num Affected
    30
    other Num At Risk
    70
    serious Num Affected
    5
    serious Num At Risk
    70
    title
    Tacro-MTX GVHD Prophylaxis
frequency Threshold
0
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Abdominal pain
  2. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Acute kidney injury
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Adult respiratory distress syndrome
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Alanine aminotransferase increased
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Anal pain
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Anaphylaxis
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      70
    term
    Anemia
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Ascites
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Aspartate aminotransferase increased
  10. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Ataxia
  11. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Atelectasis
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Bladder infection
serious Events
  1. organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Acute kidney injury
  2. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Adult respiratory distress syndrome
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Ascites
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Blood bilirubin increased
  5. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Bronchopulmonary hemorrhage
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Cardiac disorders - Other, specify
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Death NOS
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Disseminated intravascular coagulation
  9. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Encephalopathy
  10. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      70
    term
    Hepatic failure
  11. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      70
    term
    Hepatobiliary disorders - Other, specify
  12. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      70
    term
    Hypotension

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice