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NCT00142116 · ADVERSE EVENTS

Adverse events

Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia · Source last updated 2014-06-02

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
All WM Patients

Waldenstrom's Macroglobulinemia Patients

2 / 2519 / 25Not reported / Not reported

Group identifiers: EG000: All WM Patients

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
    COPD Exacerbation with respiratory failure related to long standing smoking, not related to protocol therapy.
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sudden death in a patient with longstanding hypertensive disease and arthrosclerosis while playing golf.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death

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
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
      num Events
      11
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Somnolence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Rash
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Tremors
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Bradycardia
Complete source fields
event Groups
  1. description
    Waldenstrom's Macroglobulinemia Patients
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    25
    serious Num Affected
    2
    serious Num At Risk
    25
    title
    All WM Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      25
      num Events
      11
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Somnolence
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Rash
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Tremors
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    COPD Exacerbation with respiratory failure related to long standing smoking, not related to protocol therapy.
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Sudden death in a patient with longstanding hypertensive disease and arthrosclerosis while playing golf.
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Death

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Preserved source evidence · Not medical advice