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NCT00084682 · ADVERSE EVENTS

Adverse events

Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2021-03-05

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
Treatment (Romidepsin)

Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV

12 / 1411 / 14Not reported / Not reported

Group identifiers: EG000: Treatment (Romidepsin)

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
      2
      num At Risk
      14
      num Events
      14
    term
    Anemia
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Thrombocytopenia
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hypotension
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
      num Events
      5
    term
    Fatigue
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Anorexia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Nausea
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Vomiting
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Lung infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Soft tissue infection
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombosis

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
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hypertension
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    term
    Constipation
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Diarrhea
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Dyspepsia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Pain
Complete source fields
event Groups
  1. description
    Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    14
    serious Num Affected
    12
    serious Num At Risk
    14
    title
    Treatment (Romidepsin)
frequency Threshold
5
other Events
  1. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hypertension
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      14
      num Events
      6
    term
    Constipation
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Diarrhea
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Dyspepsia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      14
    term
    Anemia
  2. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Thrombocytopenia
  3. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Hypotension
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      14
      num Events
      5
    term
    Fatigue
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Anorexia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Nausea
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Vomiting
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Lung infection
  9. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Soft tissue infection
  10. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombosis

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Preserved source evidence · Not medical advice