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

Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants

时间窗: Baseline (Enrollment Visit)

Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants

时间窗: 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

时间窗: Substudy Day 1

Number of Participants With ATA - Skin Testing Substudy

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline (Enrollment Visit)

Treatment Received Following Adjudicated Anaphylactic Event - Case Participants

时间窗: 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

时间窗: 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

时间窗: Baseline (Enrollment Visit)

Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants

时间窗: 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

时间窗: Baseline (Enrollment Visit)

Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline (Enrollment Visit)

Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.