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NCT02363439 · ADVERSE EVENTS

Adverse events

Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 · Source last updated 2018-01-09

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
During receipt of study treatment on the trial.
Other-event reporting threshold
5%

An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk

Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401

0 / 54 / 50 / 5

Group identifiers: EG000: IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk

Serious adverse events

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

    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
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Lymphadenopathy
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Conjunctival hemorrhage
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Abdominal pain lower
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Gastroesophageal reflux disease
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Vomiting
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Asthenia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Influenza like illness
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site bruising
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site discoloration
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site erythema
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Edema peripheral
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Pneumonia
    Complete source fields
    description
    An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      5
      description
      Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Lymphadenopathy
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Conjunctival hemorrhage
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Abdominal pain lower
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Gastroesophageal reflux disease
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Vomiting
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Asthenia
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Influenza like illness
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site bruising
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site discoloration
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Injection site erythema
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Edema peripheral
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      MedDRA (16.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Pneumonia
    time Frame
    During receipt of study treatment on the trial.

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice