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NCT01789255 · ADVERSE EVENTS

Adverse events

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies · Source last updated 2018-07-24

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
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)

Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.

7 / 1210 / 12Not reported / Not reported

Group identifiers: EG000: Supportive Care (Vorinostat, Tacrolimus, Methotrexate)

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dysphagia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nausea
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Vomiting
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Non-cardiac chest pain
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Immune system disorders, Other
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Abdominal infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Catheter related infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Urinary tract infection
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dehydration
  12. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Neoplasms benign, malignant and unspecified, Other

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dysphagia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Mucositis oral
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      5
    term
    Nausea
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Vomiting
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Non-cardiac chest pain
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pain
  9. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Immune system disorders, Other
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Abdominal infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Catheter related infection
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Urinary tract infection
Complete source fields
event Groups
  1. description
    Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    7
    serious Num At Risk
    12
    title
    Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
      num Events
      4
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dysphagia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Mucositis oral
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      5
    term
    Nausea
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Vomiting
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Non-cardiac chest pain
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Pain
  9. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Immune system disorders, Other
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Abdominal infection
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Catheter related infection
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Urinary tract infection
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Diarrhea
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dysphagia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Nausea
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Vomiting
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Non-cardiac chest pain
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Immune system disorders, Other
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Abdominal infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Catheter related infection
  10. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Urinary tract infection
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Dehydration
  12. organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Neoplasms benign, malignant and unspecified, Other

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Preserved source evidence · Not medical advice