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NCT00250926 · ADVERSE EVENTS

Adverse events

Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia · Source last updated 2016-04-08

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
Bortezomib, Dexamethasone, Rituximab

A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.

19 / 2323 / 23Not reported / Not reported

Group identifiers: EG000: Bortezomib, Dexamethasone, 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
    7 patients, grade 3
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      23
      num Events
      7
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 patients, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    myopathy
  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
      23
      num Events
      1
    term
    Pneumonia
  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
      23
      num Events
      1
    term
    Infection with Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    arrythmia
  9. 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
      23
      num Events
      1
    term
    anemia

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
    9 patients, grade 2
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      23
      num Events
      9
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    10 patients, grade 2
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      23
      num Events
      10
    term
    Infection without Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    18 patients, grade 2
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      23
      num Events
      18
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    8 patients, grade 2
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      23
      num Events
      8
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 2
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 2
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    hyeprglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    5 patients, grade 2.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    herpes zoster
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 patients, grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    4 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    dehydration
Complete source fields
event Groups
  1. description
    A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    19
    serious Num At Risk
    23
    title
    Bortezomib, Dexamethasone, Rituximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    9 patients, grade 2
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      23
      num Events
      9
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    10 patients, grade 2
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      23
      num Events
      10
    term
    Infection without Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    18 patients, grade 2
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      23
      num Events
      18
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    8 patients, grade 2
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      23
      num Events
      8
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 2
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 2
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    hyeprglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    5 patients, grade 2.
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    herpes zoster
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 patients, grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Pneumonia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    4 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    3 patients, grade 2
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    dehydration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    7 patients, grade 3
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      23
      num Events
      7
    term
    Peripheral Neuropathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    6 patients, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    2 patients, grade 3
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    myopathy
  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
      23
      num Events
      1
    term
    Pneumonia
  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
      23
      num Events
      1
    term
    Infection with Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    1 patient, grade 3
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    arrythmia
  9. 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
      23
      num Events
      1
    term
    anemia

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Preserved source evidence · Not medical advice