Trial Outcomes & Findings for Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (NCT NCT00813748)
NCT ID: NCT00813748
Last Updated: 2017-07-11
Results Overview
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Recruitment status
COMPLETED
Target enrollment
118 participants
Primary outcome timeframe
Baseline (Enrollment Visit)
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Omalizumab Cases
Participants who received omalizumab (Xolair) 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.
|
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.
|
|---|---|---|
|
Main Observational Study
STARTED
|
30
|
88
|
|
Main Observational Study
COMPLETED
|
30
|
88
|
|
Main Observational Study
NOT COMPLETED
|
0
|
0
|
|
Skin Test Substudy
STARTED
|
3
|
8
|
|
Skin Test Substudy
COMPLETED
|
3
|
7
|
|
Skin Test Substudy
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Omalizumab Cases
Participants who received omalizumab (Xolair) 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.
|
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.
|
|---|---|---|
|
Skin Test Substudy
Physician Decision
|
0
|
1
|
Baseline Characteristics
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Baseline characteristics by cohort
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
Omalizumab Controls
n=88 Participants
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.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 16.41 • n=93 Participants
|
45.4 years
STANDARD_DEVIATION 15.40 • n=4 Participants
|
44.7 years
STANDARD_DEVIATION 15.64 • n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Cutaneous/Subcutaneous/Mucosal + R + CV
|
2 participants
|
—
|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Cutaneous/Subcutaneous/Mucosal + R
|
24 participants
|
—
|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Cutaneous/Subcutaneous/Mucosal + R + GIT
|
1 participants
|
—
|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Cutaneous/Subcutaneous/Mucosal + CV
|
1 participants
|
—
|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
R + CV + GIT
|
1 participants
|
—
|
|
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
CV
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
Outcome measures
| Measure |
Omalizumab Cases
n=27 Participants
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.
|
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.
|
|---|---|---|
|
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
|
30 minutes
Interval 0.0 to 210.0
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled 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.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
>60-90 minutes
|
3 participants
|
—
|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
<30 minutes
|
13 participants
|
—
|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
30-60 minutes
|
8 participants
|
—
|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
>90-120 minutes
|
2 participants
|
—
|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
>120-360 minutes
|
1 participants
|
—
|
|
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Missing
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled 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.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
1 Dose
|
6 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
2 Doses
|
3 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
3 Doses
|
2 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
4-20 Doses
|
8 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
21-40 Doses
|
4 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
41-60 Doses
|
4 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
>60 Doses
|
1 participants
|
—
|
|
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
Missing
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled 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.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Antihistamine
|
23 participants
|
—
|
|
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Epinephrine
|
21 participants
|
—
|
|
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Inhaled Beta Agonists
|
13 participants
|
—
|
|
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Systemic Corticosteroids
|
19 participants
|
—
|
|
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Other
|
6 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled 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.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Life-Threatening
|
12 participants
|
—
|
|
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
In-Patient Hospitalization or its Prolongation
|
6 participants
|
—
|
|
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Other
|
12 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
|
4 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
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.
Outcome measures
| Measure |
Omalizumab Cases
n=5 Participants
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.
|
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.
|
|---|---|---|
|
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Antihistamine
|
4 participants
|
—
|
|
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Epinephrine
|
2 participants
|
—
|
|
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Inhaled Beta Agonists
|
3 participants
|
—
|
|
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Systemic Corticosteroids
|
1 participants
|
—
|
|
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Other
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
|
3 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
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.
Outcome measures
| Measure |
Omalizumab Cases
n=3 Participants
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.
|
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.
|
|---|---|---|
|
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Antihistamine
|
1 participants
|
—
|
|
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Epinephrine
|
1 participants
|
—
|
|
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Inhaled Beta Agonists
|
1 participants
|
—
|
|
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Systemic Corticosteroids
|
1 participants
|
—
|
|
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Other
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
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.
|
|---|---|---|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Calcium Channel Blocking Agents
|
3 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Cephalosporin Antibiotics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
5-Hydroxytryptamine Receptor 1 (5-HT1) Agonists
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Adrenergics/Sympathomimetics
|
3 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Aminoglycoside Antimicrobials
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Analgesic/Other Drug Combinations
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Analgesics
|
4 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Angiotensin II Receptor Antagonists
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antacids NEC
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antianxiety Agents
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antidepressants NEC
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antidiuretics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antiemetics NEC
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antihistamines
|
16 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Antipsychotic and Antimanic Agents
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Benzodiazepines
|
6 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Biguanides
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Bisphosphonates
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Bronchodilators and Antiasthmatics
|
29 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Cough Preparations
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Diuretics NEC
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Glycopeptide Antibiotics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Herbal,Homeopathic,& Dietary Supplements
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Histamine H2-receptor Antagonists
|
3 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Laxatives and Stool Softeners
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Leukotriene Receptor Antagonists
|
21 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Macrolide Antibiotics
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Miscellaneous Gastrointestinal Agents
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Muscle Relaxants
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Non-steroidal Anti-inflammatories
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Opioid Analgesics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Penicillins
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Peripheral and Cerebral Vascular Agents
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Proton Pump Inhibitors
|
10 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Salicylates
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Sedatives and Hypnotics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Selective Serotonin Re-uptake Inhibitors
|
4 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Sex Hormones
|
3 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Statins
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Steroid/Other Drug Combinations
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Steroids
|
22 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Supplements
|
2 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Thiazide Diuretics
|
1 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Thyroid Hormones
|
4 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Tricyclic Antidepressants
|
4 participants
|
—
|
|
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Vitamins and Minerals
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants.
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Outcome measures
| Measure |
Omalizumab Cases
n=30 Participants
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.
|
Omalizumab Controls
n=88 Participants
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.
|
|---|---|---|
|
Medications Within Two Weeks Prior to Blood Draw
Antiviral Agents NEC
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Benzodiazepines
|
9 participants
|
10 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Beta-adrenoceptor Blocking Agents
|
2 participants
|
4 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Biguanides
|
1 participants
|
5 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Bisphosphonates
|
1 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Bronchodilators and Antiasthmatics
|
27 participants
|
70 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Calcium Channel Blocking Agents
|
6 participants
|
12 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Calcium Compounds and Regulators
|
4 participants
|
7 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Cephalosporin Antibiotics
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Cold and Sinus Remedies
|
1 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Cough Preparations
|
0 participants
|
5 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Cox-2 Inhibitors
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Dermatologic Agents
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Diuretics NEC
|
0 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Dopaminergic Agents
|
2 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Enzymes
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Fibrates
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Folic Acid and Derivatives
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Herbal,Homeopathic,& Dietary Supplements
|
4 participants
|
16 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Histamine H2-receptor Antagonists
|
5 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Hypertensives
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Hypoglycemics NEC
|
1 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Immunosuppressants
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Insulins
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Laxatives and Stool Softeners
|
1 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Leukotriene Receptor Antagonists
|
19 participants
|
49 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Lipid Regulating Agents NEC
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Local Anesthetics
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Loop Diuretics
|
2 participants
|
9 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Macrolide Antibiotics
|
3 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Miscellaneous Cardiovascular Agents
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Miscellaneous Drugs
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Sulfonylureas
|
2 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Supplements
|
1 participants
|
12 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Mucosal Protectants
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Muscle Relaxants
|
2 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Nitrofurans
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Non Drug Therapies
|
1 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Non-steroidal Anti-inflammatories
|
6 participants
|
9 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Opioid Analgesics
|
2 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Parasympathomimetics and Antimyasthenics
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Penicillins
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Anticonvulsants NEC
|
3 participants
|
12 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antidepressants NEC
|
1 participants
|
10 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antidiuretics
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antiemetics NEC
|
2 participants
|
4 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antifungal Agents
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antiglaucoma Agents
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antigout Agents
|
0 participants
|
5 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antihistamines
|
19 participants
|
57 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antihypertensive Agents NEC
|
2 participants
|
9 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antimalarial Agents
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antimetabolites
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antimicrobial/Other Drug Combinations
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antiparkinsonism Agents NEC
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antipsychotic and Antimanic Agents
|
3 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antispasmodics and Anticholinergics
|
5 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antitrichomonal Agents
|
1 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
5-HT1 Agonists
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
5-Hydroxytryptamine Receptor 3 (5-HT3) Antagonists
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Adrenergics/Sympathomimetics
|
2 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Alpha-adrenoreceptor Antagonists
|
2 participants
|
4 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Aminoglycoside Antimicrobials
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Aminosalicylates
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Analgesic/Other Drug Combinations
|
3 participants
|
5 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Analgesics
|
5 participants
|
11 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Androgens and Anabolic Steroids
|
0 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Angiotensin II Receptor Antagonists
|
5 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Angiotensin-converting Enzyme Inhibitors
|
1 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Anorexiants and CNS Stimulants
|
2 participants
|
6 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antacids NEC
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antiallergic Agents NEC
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antiandrogens
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antianemic Agents
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antianginal Agents NEC
|
0 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Antianxiety Agents
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Anticoagulants
|
0 participants
|
4 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Peripheral and Cerebral Vascular Agents
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Pharmaceutic Aids
|
1 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Pharmacotherapeutic Class (ES) Not Known
|
0 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Phenothiazines
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Platelet Aggregation Inhibitors
|
0 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Proton Pump Inhibitors
|
13 participants
|
36 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Quinolone Antibiotics
|
0 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Salicylates
|
4 participants
|
12 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Sedatives and Hypnotics
|
2 participants
|
5 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Selective Serotonin Re-uptake Inhibitors
|
8 participants
|
15 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Sex Hormones
|
8 participants
|
14 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Statins
|
3 participants
|
20 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Steroid/Other Drug Combinations
|
0 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Steroids
|
24 participants
|
53 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Tetracyclines
|
1 participants
|
0 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Therapeutic Gases
|
2 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Thiazide Diuretics
|
3 participants
|
3 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Thiazolidinediones
|
0 participants
|
2 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Thyroid Hormones
|
5 participants
|
12 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Tricyclic Antidepressants
|
3 participants
|
4 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Vaccines, Toxoids and Serologic Agents
|
1 participants
|
1 participants
|
|
Medications Within Two Weeks Prior to Blood Draw
Vitamins and Minerals
|
9 participants
|
24 participants
|
PRIMARY outcome
Timeframe: Baseline (Enrollment Visit)Population: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
Outcome measures
| Measure |
Omalizumab Cases
n=21 Participants
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.
|
Omalizumab Controls
n=10 Participants
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.
|
|---|---|---|
|
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with Positive IgE ATA
|
0 participants
|
0 participants
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with Negative IgE ATA
|
21 participants
|
10 participants
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with Positive IgG ATA
|
0 participants
|
0 participants
|
|
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with Negative IgG ATA
|
21 participants
|
10 participants
|
PRIMARY outcome
Timeframe: Substudy Day 1Population: Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.
Outcome measures
| Measure |
Omalizumab Cases
n=3 Participants
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.
|
Omalizumab Controls
n=7 Participants
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.
|
|---|---|---|
|
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Substudy Week 10Population: Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
Outcome measures
| Measure |
Omalizumab Cases
n=3 Participants
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.
|
Omalizumab Controls
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants With ATA - Skin Testing Substudy
Participants with Positive IgG ATA
|
0 participants
|
0 participants
|
|
Number of Participants With ATA - Skin Testing Substudy
Participants with Negative IgG ATA
|
3 participants
|
6 participants
|
|
Number of Participants With ATA - Skin Testing Substudy
Participants with Positive IgE ATA
|
0 participants
|
0 participants
|
|
Number of Participants With ATA - Skin Testing Substudy
Participants with Negative IgE ATA
|
3 participants
|
6 participants
|
Adverse Events
Observational Study: Omalizumab Cases - With Anaphylaxis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Observational Study: Omalizumab Controls - Without Anaphylaxis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Skin Test Substudy: Omalizumab Cases - With Anaphylaxis
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Observational Study: Omalizumab Cases - With Anaphylaxis
n=30 participants at risk
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.
|
Observational Study: Omalizumab Controls - Without Anaphylaxis
n=88 participants at risk
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 and were from the same site or region for their matched anaphylaxis case participant.
|
Skin Test Substudy: Omalizumab Cases - With Anaphylaxis
n=3 participants at risk
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.
|
Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis
n=7 participants at risk
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 and were from the same site or region for their matched anaphylaxis case participant.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/30 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/88 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
33.3%
1/3 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/7 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
Other adverse events
| Measure |
Observational Study: Omalizumab Cases - With Anaphylaxis
n=30 participants at risk
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.
|
Observational Study: Omalizumab Controls - Without Anaphylaxis
n=88 participants at risk
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 and were from the same site or region for their matched anaphylaxis case participant.
|
Skin Test Substudy: Omalizumab Cases - With Anaphylaxis
n=3 participants at risk
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.
|
Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis
n=7 participants at risk
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 and were from the same site or region for their matched anaphylaxis case participant.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/88 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
33.3%
1/3 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/7 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/30 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/88 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
0.00%
0/3 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
14.3%
1/7 • Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks
One participant discontinued prematurely from the skin test substudy before providing data and was excluded. The term non-systematic signifies that the adverse events (AEs) were collected in a non-systematic manner where in addition to scheduled assessments, voluntary AE reporting was also allowed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER