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NCT01296815 · ADVERSE EVENTS

Adverse events

Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity · Source last updated 2015-07-27

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
1 year
Other-event reporting threshold
5%

Toxicity was graded and recorded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table)

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
HAART

Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

0 / 70 / 7Not reported / Not reported
HAART+ Bevacizumab Injection

Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

1 / 70 / 7Not reported / Not reported

Group identifiers: EG000: HAART · EG001: HAART+ Bevacizumab Injection

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
    NON_SYSTEMATIC_ASSESSMENT
    notes
    A patient had fever of 39°C after 3 days of receiving the first BVZ injection and starting ART. He was hospitalized and bronchoscopy revealed Mycobacterium avium complex pulmonary disease, so he was treated with clarithromycin and ethambutol.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    DAIDS AE
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Fever

Other reported adverse events

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

    Complete source fields
    description
    Toxicity was graded and recorded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table)
    event Groups
    1. description
      Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      7
      serious Num Affected
      0
      serious Num At Risk
      7
      title
      HAART
    2. description
      Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      7
      serious Num Affected
      1
      serious Num At Risk
      7
      title
      HAART+ Bevacizumab Injection
    frequency Threshold
    5
    serious Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      A patient had fever of 39°C after 3 days of receiving the first BVZ injection and starting ART. He was hospitalized and bronchoscopy revealed Mycobacterium avium complex pulmonary disease, so he was treated with clarithromycin and ethambutol.
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      DAIDS AE
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        7
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        7
        num Events
        1
      term
      Fever
    time Frame
    1 year

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

    Preserved source evidence · Not medical advice