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NCT00924040 · ADVERSE EVENTS

Adverse events

Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2015-10-29

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
BL22 Immunotherapy

30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.

0 / 11 / 1Not reported / Not reported

Group identifiers: EG000: BL22 Immunotherapy

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      ALT, SGPT (serum glutamic pyruvic transaminase)
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      AST, SGOT(serum glutamic oxaloacetic transaminase)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        3
      term
      Albumin, serum-low (hypoalbuminemia)
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Lightheadedness
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Constitutional Symptoms - Other (Specify, __)
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Rash, tick bite
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Dermatology/Skin - Other (Specify, __)
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Diarrhea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Edema: limb
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Fatigue (asthenia, lethargy, malaise)
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Heartburn/dyspepsia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        3
      term
      Hemoglobin
    Complete source fields
    event Groups
    1. description
      30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      BL22 Immunotherapy
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      ALT, SGPT (serum glutamic pyruvic transaminase)
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      AST, SGOT(serum glutamic oxaloacetic transaminase)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        3
      term
      Albumin, serum-low (hypoalbuminemia)
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Lightheadedness
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Constitutional Symptoms - Other (Specify, __)
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Rash, tick bite
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Dermatology/Skin - Other (Specify, __)
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Diarrhea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Edema: limb
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Fatigue (asthenia, lethargy, malaise)
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        4
      term
      Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Heartburn/dyspepsia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAEv3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        3
      term
      Hemoglobin

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    Preserved source evidence · Not medical advice