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NCT01244906 · ADVERSE EVENTS

Adverse events

Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant · Source last updated 2015-05-01

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Reduced Intensity Allogeneic Stem Cell Transplantation

All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

10 / 2626 / 26Not reported / Not reported

Group identifiers: EG000: Reduced Intensity Allogeneic Stem Cell 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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    pneumonia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Acute Cholecystitis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    GI bleeding
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    pulmonary embolism
  5. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    cellulitis
  6. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    VOD
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Severe 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. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      26
    term
    Nausea
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    "cold sweats"
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    "cold" feeling
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    abdominal bloating
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    abdominal cramps
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    term
    abdominal discomfort/pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    abdominal distention
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    abdominal tenderness
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    agitation
  10. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      26
    term
    increased alkaline phosphatase
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    alopecia
  12. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      26
    term
    increased alanine aminotransferase
Complete source fields
event Groups
  1. description
    All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis. Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    10
    serious Num At Risk
    26
    title
    Reduced Intensity Allogeneic Stem Cell Transplantation
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      26
    term
    Nausea
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    "cold sweats"
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
    term
    "cold" feeling
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    abdominal bloating
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      26
    term
    abdominal cramps
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    term
    abdominal discomfort/pain
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    abdominal distention
  8. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    abdominal tenderness
  9. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    agitation
  10. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      26
    term
    increased alkaline phosphatase
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
    term
    alopecia
  12. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      26
    term
    increased alanine aminotransferase
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      3
    term
    pneumonia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Acute Cholecystitis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
      num Events
      2
    term
    GI bleeding
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    pulmonary embolism
  5. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    cellulitis
  6. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    VOD
  7. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    term
    Severe Hyperglycemia

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Preserved source evidence · Not medical advice