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NCT00389818 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma · Source last updated 2018-06-06

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
DR-COP

Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.

26 / 4038 / 40Not reported / Not reported

Group identifiers: EG000: DR-COP

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
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      4
    term
    Febrile Neutropenia
  3. organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    term
    Optic nerve disorder
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Abdominal pain
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Constipation
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dysphagia
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastric hemorrhage
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileal obstruction
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileal perforation
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileus
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Nausea
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Small intestinal obstruction

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
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      19
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    term
    Abdominal pain
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      19
    term
    Nausea
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      17
    term
    Vomiting
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      6
    term
    Blood and lymphatic system disorders, other
  6. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Sinus tachycardia
  7. organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Ear and labyrinth disorders, other
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      14
    term
    Constipation
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      8
    term
    Diarrhea
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Dysphagia
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Gastric ulcer
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      10
    term
    Mucositis, oral
Complete source fields
event Groups
  1. description
    Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    40
    serious Num Affected
    26
    serious Num At Risk
    40
    title
    DR-COP
frequency Threshold
5
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      19
    term
    Anemia
  2. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    term
    Abdominal pain
  3. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      40
      num Events
      19
    term
    Nausea
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      40
      num Events
      17
    term
    Vomiting
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      6
    term
    Blood and lymphatic system disorders, other
  6. organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Sinus tachycardia
  7. organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Ear and labyrinth disorders, other
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      40
      num Events
      14
    term
    Constipation
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      8
    term
    Diarrhea
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Dysphagia
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Gastric ulcer
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      40
      num Events
      10
    term
    Mucositis, oral
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      4
    term
    Febrile Neutropenia
  3. organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      3
    term
    Optic nerve disorder
  4. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      3
    term
    Abdominal pain
  5. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Constipation
  6. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Dysphagia
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastric hemorrhage
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileal obstruction
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileal perforation
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Ileus
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Nausea
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Small intestinal obstruction

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