Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allergic Asthma
- Sponsor
- Genentech, Inc.
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Time Frame: Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Time Frame: Baseline (Enrollment Visit)
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Time Frame: Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy
Time Frame: Substudy Week 10
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
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.
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.
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time Frame: Baseline (Enrollment Visit)
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, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Time Frame: Baseline (Enrollment Visit)
Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.
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.
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Time Frame: Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Time Frame: Baseline (Enrollment Visit)
Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time Frame: Baseline (Enrollment Visit)
Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Medications Within Two Weeks Prior to Blood Draw
Time Frame: Baseline (Enrollment Visit)
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Time Frame: Baseline (Enrollment Visit)
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.