Clinical Trial: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

Brief Summary: This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

Detailed Summary:
Sponsor: Genentech, Inc.

Current Primary Outcome:

  • Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants [ Time Frame: Baseline (Enrollment Visit) ]
    Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
  • Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants [ Time Frame: Baseline (Enrollment Visit) ]
  • Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants [ Time Frame: Baseline (Enrollment Visit) ]
    Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.
  • Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants [ Time Frame: Baseline (Enrollment Visit) ]
    Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.
  • Treatment Received Following Adjudicated Anaphylactic Event - Case Participants [ Time Frame: Baseline (Enrollment Visit) ]
    Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemi

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Genentech, Inc.

    Dates:
    Date Received: December 22, 2008
    Date Started: March 2009
    Date Completion:
    Last Updated: August 14, 2015
    Last Verified: August 2015