Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00143845 · ADVERSE EVENTS

Adverse events

Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant · Source last updated 2017-03-08

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
Immunosuppression Taper

Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).

42 / 5430 / 54Not reported / Not reported

Group identifiers: EG000: Immunosuppression Taper

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
      10
      num At Risk
      54
    term
    Diarrhea
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    term
    GVHD
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    DVT
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      54
    term
    Infection
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Primary Graft Failure
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Fever
  7. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Relapsed Disease
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    term
    Hypotension
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    Vomiting
  10. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Vertigo
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Headache
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Back 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. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      54
    term
    Hypomagnesemia
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      54
    term
    Hyperglycemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
    term
    Hypoglycemia
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      54
    term
    Hypocalcemia
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
    term
    Hypercalcemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      54
    term
    Hypermagnesemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      54
    term
    Hyperkalemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      54
    term
    Hypokalemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      54
    term
    Hyponatremia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Hypernatremia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      54
    term
    Creatinine
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
    term
    Esophogitis
Complete source fields
event Groups
  1. description
    Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    54
    serious Num Affected
    42
    serious Num At Risk
    54
    title
    Immunosuppression Taper
frequency Threshold
5
other Events
  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      54
    term
    Hypomagnesemia
  2. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      54
    term
    Hyperglycemia
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
    term
    Hypoglycemia
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      54
    term
    Hypocalcemia
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
    term
    Hypercalcemia
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      54
    term
    Hypermagnesemia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      54
    term
    Hyperkalemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      54
    term
    Hypokalemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      54
    term
    Hyponatremia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Hypernatremia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      54
    term
    Creatinine
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
    term
    Esophogitis
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      54
    term
    Diarrhea
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    term
    GVHD
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    DVT
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      54
    term
    Infection
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Primary Graft Failure
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    term
    Fever
  7. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Relapsed Disease
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    term
    Hypotension
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    term
    Vomiting
  10. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Vertigo
  11. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Headache
  12. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    term
    Back Pain

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

Preserved source evidence · Not medical advice