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NCT00142168 · ADVERSE EVENTS

Adverse events

CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia · Source last updated 2016-04-21

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
Lenalidomide and Rituximab

Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

11 / 168 / 16Not reported / Not reported

Group identifiers: EG000: Lenalidomide and 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
    notes
    5 patients developed grade 3 neutropenia
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      16
      num Events
      5
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    arrythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    pulmonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    pleural effusion

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
    1 patient grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
      num Events
      8
    term
    Anemia
Complete source fields
event Groups
  1. description
    Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    16
    serious Num Affected
    11
    serious Num At Risk
    16
    title
    Lenalidomide and Rituximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
      num Events
      8
    term
    Anemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    5 patients developed grade 3 neutropenia
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      16
      num Events
      5
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    arrythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    pulmonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    pleural effusion

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Preserved source evidence · Not medical advice