N/A
N=118
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Allergic Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00813748 ↗Enrolled (actual)
118
Serious AEs
0.8%
Results posted
Sep 2015
Primary outcome: Primary: Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants — 24; 2; 1; 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Xolair (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants |
24; 2; 1; 1; 1; 1 | — |
| PRIMARY Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants |
30 | — |
| PRIMARY Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants |
13; 8; 3; 2; 1; 3 | — |
| PRIMARY Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants |
6; 3; 2; 8; 4; 4 | — |
| PRIMARY Treatment Received Following Adjudicated Anaphylactic Event - Case Participants |
23; 21; 13; 19; 6 | — |
| PRIMARY Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants |
12; 6; 12 | — |
| PRIMARY Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants |
4 | — |
| PRIMARY Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants |
7 | — |
| PRIMARY Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants |
4; 2; 3; 1; 1 | — |
| PRIMARY Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants |
3 | — |
| PRIMARY Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants |
1; 1; 1; 1; 1 | — |
| PRIMARY Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants |
1; 3; 1; 2; 4; 2 | — |
| PRIMARY Medications Within Two Weeks Prior to Blood Draw |
0; 2; 1; 0; 2; 0 | — |
| PRIMARY Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study |
0; 0; 21; 10; 0; 0 | — |
| PRIMARY Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy |
0; 2 | — |
| PRIMARY Number of Participants With ATA - Skin Testing Substudy |
0; 0; 3; 6; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00813748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.