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NCT00054639 · ADVERSE EVENTS

Adverse events

Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma · Source last updated 2014-05-28

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
2 Years, 10 Months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oblimersen + Rituximab

Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.

15 / 4646 / 46Not reported / Not reported

Group identifiers: EG000: Oblimersen + Rituximab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      46
      num Events
      7
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      46
      num Events
      3
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Fever

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      46
      num Events
      23
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      46
      num Events
      8
    term
    Thrompbocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      46
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      46
      num Events
      17
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      46
      num Events
      9
    term
    Odema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      46
      num Events
      9
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
      num Events
      5
    term
    Fever
Complete source fields
event Groups
  1. description
    Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    46
    serious Num Affected
    15
    serious Num At Risk
    46
    title
    Oblimersen + Rituximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      46
      num Events
      23
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      46
      num Events
      8
    term
    Thrompbocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      46
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      46
      num Events
      17
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      46
      num Events
      9
    term
    Odema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      46
      num Events
      9
    term
    Rash
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 1 and 2
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      46
      num Events
      5
    term
    Fever
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      46
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      46
      num Events
      7
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      46
      num Events
      3
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      46
      num Events
      1
    term
    Fever
time Frame
2 Years, 10 Months

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Preserved source evidence · Not medical advice