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NCT00601718 · ADVERSE EVENTS

Adverse events

Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma · Source last updated 2017-05-25

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 (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy

Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO rituximab: Given IV ifosfamide: Given IV carboplatin: Given IV etoposide: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies gene expression analysis: Correlative studies

10 / 2925 / 29Not reported / Not reported

Group identifiers: EG000: Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy

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
      1
      num At Risk
      29
    term
    Dyspnea
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Encephalopathy
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    term
    Febrile neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Nausea/Vomiting
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Diarrhea
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Hypotension
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Allergic reaction
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Syncope

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
      8
      num At Risk
      29
    term
    Febrile neutropenia
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
    term
    Infection
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
    term
    Nausea
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    term
    Dehydration
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    term
    Anorexia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Vomiting
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      29
    term
    Hypophasphataemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      29
    term
    Hypokalaemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    Hyponatraemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    Hypercalcemia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    AST/ALT
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    DVT
Complete source fields
event Groups
  1. description
    Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. vorinostat: Given PO rituximab: Given IV ifosfamide: Given IV carboplatin: Given IV etoposide: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies gene expression analysis: Correlative studies
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    29
    serious Num Affected
    10
    serious Num At Risk
    29
    title
    Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
    term
    Febrile neutropenia
  2. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
    term
    Infection
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      29
    term
    Nausea
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      29
    term
    Dehydration
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    term
    Anorexia
  6. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Vomiting
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      29
    term
    Hypophasphataemia
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      29
    term
    Hypokalaemia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    Hyponatraemia
  10. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    Hypercalcemia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
    term
    AST/ALT
  12. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    DVT
serious Events
  1. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Dyspnea
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Encephalopathy
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      29
    term
    Febrile neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Nausea/Vomiting
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Diarrhea
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Hypotension
  7. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Allergic reaction
  8. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
    term
    Syncope

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Preserved source evidence · Not medical advice