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NCT01529827 · ADVERSE EVENTS

Adverse events

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2019-09-24

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Reduced Intensity Allogeneic PBSCT)

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT

17 / 941 / 94Not reported / Not reported

Group identifiers: EG000: Treatment (Reduced Intensity Allogeneic PBSCT)

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
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      8
    term
    Multi-organ failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
      num Events
      22
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
      num Events
      18
    term
    Acute graft versus host disease in intestine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
      num Events
      13
    term
    Graft versus host disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      5
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      8
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Blood culture positive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Gram stain positive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Muscular weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Pleuritic pain

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Acute graft versus host disease in intestine
Complete source fields
event Groups
  1. description
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    94
    serious Num Affected
    17
    serious Num At Risk
    94
    title
    Treatment (Reduced Intensity Allogeneic PBSCT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Acute graft versus host disease in intestine
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      8
    term
    Multi-organ failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
      num Events
      22
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      94
      num Events
      18
    term
    Acute graft versus host disease in intestine
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      94
      num Events
      13
    term
    Graft versus host disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      5
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      8
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Blood culture positive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Gram stain positive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Muscular weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      94
      num Events
      4
    term
    Pleuritic pain

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Preserved source evidence · Not medical advice