Allergic Asthma
Conditions
Keywords
Asthma, Anaphylaxis
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.
Interventions
DRUGXolair
Sponsors
Genentech, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for Cases: * Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair Inclusion Criteria for Controls: * At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment * At least one dose of Xolair in the 18 months before the date of the case event (index date) * No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | 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 | Baseline (Enrollment Visit) | — |
| Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | 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 | 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 | 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 | 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. |
| Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants | Baseline (Enrollment Visit) | — |
| Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants | Baseline (Enrollment Visit) | — |
| Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | 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. |
| Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants | Baseline (Enrollment Visit) | — |
| Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | 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 Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | 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. |
| Medications Within Two Weeks Prior to Blood Draw | 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 | Baseline (Enrollment Visit) | Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported. |
| Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy | Substudy Day 1 | — |
| Number of Participants With ATA - Skin Testing Substudy | Substudy Week 10 | Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab Cases Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. | 30 |
| Omalizumab Controls Participants who received omalizumab within 18 months (either before or after) of the matched case participant's anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant. | 88 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Skin Test Substudy | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Omalizumab Cases | Omalizumab Controls | Total |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 16.41 | 45.4 years STANDARD_DEVIATION 15.4 | 44.7 years STANDARD_DEVIATION 15.64 |
| Sex: Female, Male Female | 27 Participants | 60 Participants | 87 Participants |
| Sex: Female, Male Male | 3 Participants | 28 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 88 | 1 / 3 | 1 / 7 |
| serious Total, serious adverse events | 0 / 30 | 0 / 88 | 1 / 3 | 0 / 7 |
Outcome results
Primary
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
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.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | <30 minutes | 13 participants |
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | 30-60 minutes | 8 participants |
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | >60-90 minutes | 3 participants |
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | >90-120 minutes | 2 participants |
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | >120-360 minutes | 1 participants |
| Omalizumab Cases | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | Missing | 3 participants |
Primary
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | 5-Hydroxytryptamine Receptor 1 (5-HT1) Agonists | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Adrenergics/Sympathomimetics | 3 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Aminoglycoside Antimicrobials | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Analgesic/Other Drug Combinations | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Analgesics | 4 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Angiotensin II Receptor Antagonists | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antacids NEC | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antianxiety Agents | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antidepressants NEC | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antidiuretics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antiemetics NEC | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antihistamines | 16 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Antipsychotic and Antimanic Agents | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Benzodiazepines | 6 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Biguanides | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Bisphosphonates | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Bronchodilators and Antiasthmatics | 29 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Calcium Channel Blocking Agents | 3 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Cephalosporin Antibiotics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Cough Preparations | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Diuretics NEC | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Glycopeptide Antibiotics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Herbal,Homeopathic,& Dietary Supplements | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Histamine H2-receptor Antagonists | 3 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Laxatives and Stool Softeners | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Leukotriene Receptor Antagonists | 21 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Macrolide Antibiotics | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Miscellaneous Gastrointestinal Agents | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Muscle Relaxants | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Non-steroidal Anti-inflammatories | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Opioid Analgesics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Penicillins | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Peripheral and Cerebral Vascular Agents | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Proton Pump Inhibitors | 10 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Salicylates | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Sedatives and Hypnotics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Selective Serotonin Re-uptake Inhibitors | 4 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Sex Hormones | 3 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Statins | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Steroid/Other Drug Combinations | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Steroids | 22 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Supplements | 2 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Thiazide Diuretics | 1 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Thyroid Hormones | 4 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Tricyclic Antidepressants | 4 participants |
| Omalizumab Cases | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Vitamins and Minerals | 2 participants |
Primary
Medications Within Two Weeks Prior to Blood Draw
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiglaucoma Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Dopaminergic Agents | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antacids NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Enzymes | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antigout Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Fibrates | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Analgesic/Other Drug Combinations | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Folic Acid and Derivatives | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antihistamines | 19 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Herbal,Homeopathic,& Dietary Supplements | 4 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiallergic Agents NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Histamine H2-receptor Antagonists | 5 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antihypertensive Agents NEC | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Hypertensives | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Alpha-adrenoreceptor Antagonists | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Hypoglycemics NEC | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antimalarial Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Immunosuppressants | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiandrogens | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Insulins | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antimetabolites | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Laxatives and Stool Softeners | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Analgesics | 5 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Leukotriene Receptor Antagonists | 19 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antimicrobial/Other Drug Combinations | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Lipid Regulating Agents NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antianemic Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Local Anesthetics | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiparkinsonism Agents NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Loop Diuretics | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Supplements | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Macrolide Antibiotics | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antipsychotic and Antimanic Agents | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Miscellaneous Cardiovascular Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antianginal Agents NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Miscellaneous Drugs | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antispasmodics and Anticholinergics | 5 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Mucosal Protectants | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Androgens and Anabolic Steroids | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Muscle Relaxants | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antitrichomonal Agents | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Nitrofurans | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antianxiety Agents | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Non Drug Therapies | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiviral Agents NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Non-steroidal Anti-inflammatories | 6 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Aminoglycoside Antimicrobials | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Opioid Analgesics | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Benzodiazepines | 9 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Parasympathomimetics and Antimyasthenics | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Anticoagulants | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Penicillins | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Beta-adrenoceptor Blocking Agents | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Peripheral and Cerebral Vascular Agents | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Angiotensin II Receptor Antagonists | 5 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Pharmaceutic Aids | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Biguanides | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Pharmacotherapeutic Class (ES) Not Known | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Anticonvulsants NEC | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Phenothiazines | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Bisphosphonates | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Platelet Aggregation Inhibitors | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Adrenergics/Sympathomimetics | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Proton Pump Inhibitors | 13 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Bronchodilators and Antiasthmatics | 27 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Quinolone Antibiotics | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antidepressants NEC | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Salicylates | 4 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Calcium Channel Blocking Agents | 6 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Sedatives and Hypnotics | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Angiotensin-converting Enzyme Inhibitors | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Selective Serotonin Re-uptake Inhibitors | 8 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Calcium Compounds and Regulators | 4 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Sex Hormones | 8 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antidiuretics | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Statins | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Cephalosporin Antibiotics | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Steroid/Other Drug Combinations | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Aminosalicylates | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Steroids | 24 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Cold and Sinus Remedies | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Sulfonylureas | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antiemetics NEC | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Tetracyclines | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Cough Preparations | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Therapeutic Gases | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Anorexiants and CNS Stimulants | 2 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Thiazide Diuretics | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Cox-2 Inhibitors | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Thiazolidinediones | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Antifungal Agents | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Thyroid Hormones | 5 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Dermatologic Agents | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Tricyclic Antidepressants | 3 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | 5-Hydroxytryptamine Receptor 3 (5-HT3) Antagonists | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Vaccines, Toxoids and Serologic Agents | 1 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Diuretics NEC | 0 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | Vitamins and Minerals | 9 participants |
| Omalizumab Cases | Medications Within Two Weeks Prior to Blood Draw | 5-HT1 Agonists | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Vitamins and Minerals | 24 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Sulfonylureas | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | 5-HT1 Agonists | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | 5-Hydroxytryptamine Receptor 3 (5-HT3) Antagonists | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Adrenergics/Sympathomimetics | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Alpha-adrenoreceptor Antagonists | 4 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Aminoglycoside Antimicrobials | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Aminosalicylates | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Analgesic/Other Drug Combinations | 5 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Analgesics | 11 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Androgens and Anabolic Steroids | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Angiotensin II Receptor Antagonists | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Angiotensin-converting Enzyme Inhibitors | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Anorexiants and CNS Stimulants | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antacids NEC | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiallergic Agents NEC | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiandrogens | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antianemic Agents | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antianginal Agents NEC | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antianxiety Agents | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Anticoagulants | 4 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Anticonvulsants NEC | 12 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antidepressants NEC | 10 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antidiuretics | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiemetics NEC | 4 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antifungal Agents | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiglaucoma Agents | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antigout Agents | 5 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antihistamines | 57 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antihypertensive Agents NEC | 9 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antimalarial Agents | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antimetabolites | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antimicrobial/Other Drug Combinations | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiparkinsonism Agents NEC | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antipsychotic and Antimanic Agents | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antispasmodics and Anticholinergics | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antitrichomonal Agents | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Antiviral Agents NEC | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Benzodiazepines | 10 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Beta-adrenoceptor Blocking Agents | 4 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Biguanides | 5 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Bisphosphonates | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Bronchodilators and Antiasthmatics | 70 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Calcium Channel Blocking Agents | 12 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Calcium Compounds and Regulators | 7 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Cephalosporin Antibiotics | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Cold and Sinus Remedies | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Cough Preparations | 5 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Cox-2 Inhibitors | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Dermatologic Agents | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Diuretics NEC | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Dopaminergic Agents | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Enzymes | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Fibrates | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Folic Acid and Derivatives | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Herbal,Homeopathic,& Dietary Supplements | 16 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Histamine H2-receptor Antagonists | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Hypertensives | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Hypoglycemics NEC | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Immunosuppressants | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Insulins | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Laxatives and Stool Softeners | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Leukotriene Receptor Antagonists | 49 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Lipid Regulating Agents NEC | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Local Anesthetics | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Loop Diuretics | 9 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Macrolide Antibiotics | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Miscellaneous Cardiovascular Agents | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Miscellaneous Drugs | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Mucosal Protectants | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Muscle Relaxants | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Nitrofurans | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Non Drug Therapies | 1 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Non-steroidal Anti-inflammatories | 9 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Opioid Analgesics | 6 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Parasympathomimetics and Antimyasthenics | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Penicillins | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Peripheral and Cerebral Vascular Agents | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Pharmaceutic Aids | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Pharmacotherapeutic Class (ES) Not Known | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Phenothiazines | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Platelet Aggregation Inhibitors | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Proton Pump Inhibitors | 36 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Quinolone Antibiotics | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Salicylates | 12 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Sedatives and Hypnotics | 5 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Selective Serotonin Re-uptake Inhibitors | 15 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Sex Hormones | 14 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Statins | 20 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Steroid/Other Drug Combinations | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Steroids | 53 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Supplements | 12 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Tetracyclines | 0 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Therapeutic Gases | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Thiazide Diuretics | 3 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Thiazolidinediones | 2 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Thyroid Hormones | 12 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Tricyclic Antidepressants | 4 participants |
| Omalizumab Controls | Medications Within Two Weeks Prior to Blood Draw | Vaccines, Toxoids and Serologic Agents | 1 participants |
Primary
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omalizumab Cases | Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants | 4 participants |
Primary
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Positive IgG ATA | 0 participants |
| Omalizumab Cases | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Negative IgG ATA | 21 participants |
| Omalizumab Cases | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Positive IgE ATA | 0 participants |
| Omalizumab Cases | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Negative IgE ATA | 21 participants |
| Omalizumab Controls | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Negative IgE ATA | 10 participants |
| Omalizumab Controls | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Positive IgG ATA | 0 participants |
| Omalizumab Controls | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Positive IgE ATA | 0 participants |
| Omalizumab Controls | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with Negative IgG ATA | 10 participants |
Primary
Number of Participants With ATA - Skin Testing Substudy
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
Time frame: Substudy Week 10
Population: Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Number of Participants With ATA - Skin Testing Substudy | Participants with Positive IgE ATA | 0 participants |
| Omalizumab Cases | Number of Participants With ATA - Skin Testing Substudy | Participants with Positive IgG ATA | 0 participants |
| Omalizumab Cases | Number of Participants With ATA - Skin Testing Substudy | Participants with Negative IgG ATA | 3 participants |
| Omalizumab Cases | Number of Participants With ATA - Skin Testing Substudy | Participants with Negative IgE ATA | 3 participants |
| Omalizumab Controls | Number of Participants With ATA - Skin Testing Substudy | Participants with Negative IgE ATA | 6 participants |
| Omalizumab Controls | Number of Participants With ATA - Skin Testing Substudy | Participants with Positive IgE ATA | 0 participants |
| Omalizumab Controls | Number of Participants With ATA - Skin Testing Substudy | Participants with Negative IgG ATA | 6 participants |
| Omalizumab Controls | Number of Participants With ATA - Skin Testing Substudy | Participants with Positive IgG ATA | 0 participants |
Primary
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Cutaneous/Subcutaneous/Mucosal + R | 24 participants |
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Cutaneous/Subcutaneous/Mucosal + R + CV | 2 participants |
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Cutaneous/Subcutaneous/Mucosal + R + GIT | 1 participants |
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Cutaneous/Subcutaneous/Mucosal + CV | 1 participants |
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | R + CV + GIT | 1 participants |
| Omalizumab Cases | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | CV | 1 participants |
Primary
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Time frame: Substudy Day 1
Population: Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omalizumab Cases | Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy | 0 participants |
| Omalizumab Controls | Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy | 2 participants |
Primary
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omalizumab Cases | Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants | 7 participants |
Primary
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omalizumab Cases | Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants | 3 participants |
Primary
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
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 frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants | Life-Threatening | 12 participants |
| Omalizumab Cases | Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants | In-Patient Hospitalization or its Prolongation | 6 participants |
| Omalizumab Cases | Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants | Other | 12 participants |
Primary
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Omalizumab Cases | Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | 30 minutes |
Primary
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
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.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 1 Dose | 6 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 2 Doses | 3 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 3 Doses | 2 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 4-20 Doses | 8 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 21-40 Doses | 4 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | 41-60 Doses | 4 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | >60 Doses | 1 participants |
| Omalizumab Cases | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | Missing | 2 participants |
Primary
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
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.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Antihistamine | 4 participants |
| Omalizumab Cases | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Epinephrine | 2 participants |
| Omalizumab Cases | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Inhaled Beta Agonists | 3 participants |
| Omalizumab Cases | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Systemic Corticosteroids | 1 participants |
| Omalizumab Cases | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Other | 1 participants |
Primary
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
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.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Antihistamine | 1 participants |
| Omalizumab Cases | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Epinephrine | 1 participants |
| Omalizumab Cases | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Inhaled Beta Agonists | 1 participants |
| Omalizumab Cases | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Systemic Corticosteroids | 1 participants |
| Omalizumab Cases | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Other | 1 participants |
Primary
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
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.
Time frame: Baseline (Enrollment Visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab Cases | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Antihistamine | 23 participants |
| Omalizumab Cases | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Epinephrine | 21 participants |
| Omalizumab Cases | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Inhaled Beta Agonists | 13 participants |
| Omalizumab Cases | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Systemic Corticosteroids | 19 participants |
| Omalizumab Cases | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Other | 6 participants |