X-PAND: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00813748
Collaborator
(none)
118
7
58.1
16.9
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
118 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing
Actual Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Jan 1, 2014
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site | Los Angeles | California | United States | 90025 |
| 2 | Investigational Site | Valrico | Florida | United States | 33596 |
| 3 | Investigational Site | Hinsdale | Illinois | United States | 60521 |
| 4 | Investigational Site | Kansas City | Missouri | United States | 64111 |
| 5 | Investigational Site | New York | New York | United States | 10022 |
| 6 | Investigational Site | Blue Bell | Pennsylvania | United States | 19422 |
| 7 | Investigational Site | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Abdelkader Rahmaoui, M.D., Genentech, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00813748
Other Study ID Numbers:
- Q4458g
First Posted:
Dec 23, 2008
Last Update Posted:
Jul 11, 2017
Last Verified:
Jun 1, 2017
Keywords provided by Genentech, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Main Observational Study | ||
| STARTED | 30 | 88 |
| COMPLETED | 30 | 88 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Main Observational Study | ||
| STARTED | 3 | 8 |
| COMPLETED | 3 | 7 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 30 | 88 | 118 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
42.7
(16.41)
|
45.4
(15.40)
|
44.7
(15.64)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
90%
|
60
68.2%
|
87
73.7%
|
| Male |
3
10%
|
28
31.8%
|
31
26.3%
|
Outcome Measures
| Title | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Cutaneous/Subcutaneous/Mucosal + R |
24
80%
|
| Cutaneous/Subcutaneous/Mucosal + R + CV |
2
6.7%
|
| Cutaneous/Subcutaneous/Mucosal + R + GIT |
1
3.3%
|
| Cutaneous/Subcutaneous/Mucosal + CV |
1
3.3%
|
| R + CV + GIT |
1
3.3%
|
| CV |
1
3.3%
|
| Title | Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants |
|---|---|
| Description | |
| Time Frame | Baseline (Enrollment Visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 27 |
| Median (Full Range) [minutes] |
30
|
| Title | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| <30 minutes |
13
43.3%
|
| 30-60 minutes |
8
26.7%
|
| >60-90 minutes |
3
10%
|
| >90-120 minutes |
2
6.7%
|
| >120-360 minutes |
1
3.3%
|
| Missing |
3
10%
|
| Title | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| 1 Dose |
6
20%
|
| 2 Doses |
3
10%
|
| 3 Doses |
2
6.7%
|
| 4-20 Doses |
8
26.7%
|
| 21-40 Doses |
4
13.3%
|
| 41-60 Doses |
4
13.3%
|
| >60 Doses |
1
3.3%
|
| Missing |
2
6.7%
|
| Title | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Antihistamine |
23
76.7%
|
| Epinephrine |
21
70%
|
| Inhaled Beta Agonists |
13
43.3%
|
| Systemic Corticosteroids |
19
63.3%
|
| Other |
6
20%
|
| Title | Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Life-Threatening |
12
40%
|
| In-Patient Hospitalization or its Prolongation |
6
20%
|
| Other |
12
40%
|
| Title | Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants |
|---|---|
| Description | |
| Time Frame | Baseline (Enrollment Visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Number [participants] |
4
13.3%
|
| Title | Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants |
|---|---|
| Description | |
| Time Frame | Baseline (Enrollment Visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Number [participants] |
7
23.3%
|
| Title | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 5 |
| Antihistamine |
4
13.3%
|
| Epinephrine |
2
6.7%
|
| Inhaled Beta Agonists |
3
10%
|
| Systemic Corticosteroids |
1
3.3%
|
| Other |
1
3.3%
|
| Title | Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants |
|---|---|
| Description | |
| Time Frame | Baseline (Enrollment Visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| Number [participants] |
3
10%
|
| Title | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 3 |
| Antihistamine |
1
3.3%
|
| Epinephrine |
1
3.3%
|
| Inhaled Beta Agonists |
1
3.3%
|
| Systemic Corticosteroids |
1
3.3%
|
| Other |
1
3.3%
|
| Title | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 30 |
| 5-Hydroxytryptamine Receptor 1 (5-HT1) Agonists |
1
3.3%
|
| Adrenergics/Sympathomimetics |
3
10%
|
| Aminoglycoside Antimicrobials |
1
3.3%
|
| Analgesic/Other Drug Combinations |
2
6.7%
|
| Analgesics |
4
13.3%
|
| Angiotensin II Receptor Antagonists |
2
6.7%
|
| Antacids NEC |
1
3.3%
|
| Antianxiety Agents |
1
3.3%
|
| Antidepressants NEC |
1
3.3%
|
| Antidiuretics |
1
3.3%
|
| Antiemetics NEC |
2
6.7%
|
| Antihistamines |
16
53.3%
|
| Antipsychotic and Antimanic Agents |
2
6.7%
|
| Benzodiazepines |
6
20%
|
| Biguanides |
1
3.3%
|
| Bisphosphonates |
1
3.3%
|
| Bronchodilators and Antiasthmatics |
29
96.7%
|
| Calcium Channel Blocking Agents |
3
10%
|
| Cephalosporin Antibiotics |
1
3.3%
|
| Cough Preparations |
2
6.7%
|
| Diuretics NEC |
1
3.3%
|
| Glycopeptide Antibiotics |
1
3.3%
|
| Herbal,Homeopathic,& Dietary Supplements |
1
3.3%
|
| Histamine H2-receptor Antagonists |
3
10%
|
| Laxatives and Stool Softeners |
1
3.3%
|
| Leukotriene Receptor Antagonists |
21
70%
|
| Macrolide Antibiotics |
2
6.7%
|
| Miscellaneous Gastrointestinal Agents |
1
3.3%
|
| Muscle Relaxants |
1
3.3%
|
| Non-steroidal Anti-inflammatories |
2
6.7%
|
| Opioid Analgesics |
1
3.3%
|
| Penicillins |
1
3.3%
|
| Peripheral and Cerebral Vascular Agents |
1
3.3%
|
| Proton Pump Inhibitors |
10
33.3%
|
| Salicylates |
1
3.3%
|
| Sedatives and Hypnotics |
1
3.3%
|
| Selective Serotonin Re-uptake Inhibitors |
4
13.3%
|
| Sex Hormones |
3
10%
|
| Statins |
2
6.7%
|
| Steroid/Other Drug Combinations |
1
3.3%
|
| Steroids |
22
73.3%
|
| Supplements |
2
6.7%
|
| Thiazide Diuretics |
1
3.3%
|
| Thyroid Hormones |
4
13.3%
|
| Tricyclic Antidepressants |
4
13.3%
|
| Vitamins and Minerals |
2
6.7%
|
| Title | Medications Within Two Weeks Prior to Blood Draw |
|---|---|
| Description | Number of participants in each medication class is reported. Participants could have received more than 1 medication class. |
| Time Frame | Baseline (Enrollment Visit) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 30 | 88 |
| 5-HT1 Agonists |
0
0%
|
2
2.3%
|
| 5-Hydroxytryptamine Receptor 3 (5-HT3) Antagonists |
1
3.3%
|
0
0%
|
| Adrenergics/Sympathomimetics |
2
6.7%
|
0
0%
|
| Alpha-adrenoreceptor Antagonists |
2
6.7%
|
4
4.5%
|
| Aminoglycoside Antimicrobials |
0
0%
|
1
1.1%
|
| Aminosalicylates |
0
0%
|
1
1.1%
|
| Analgesic/Other Drug Combinations |
3
10%
|
5
5.7%
|
| Analgesics |
5
16.7%
|
11
12.5%
|
| Androgens and Anabolic Steroids |
0
0%
|
3
3.4%
|
| Angiotensin II Receptor Antagonists |
5
16.7%
|
6
6.8%
|
| Angiotensin-converting Enzyme Inhibitors |
1
3.3%
|
6
6.8%
|
| Anorexiants and CNS Stimulants |
2
6.7%
|
6
6.8%
|
| Antacids NEC |
0
0%
|
1
1.1%
|
| Antiallergic Agents NEC |
0
0%
|
1
1.1%
|
| Antiandrogens |
0
0%
|
2
2.3%
|
| Antianemic Agents |
0
0%
|
2
2.3%
|
| Antianginal Agents NEC |
0
0%
|
1
1.1%
|
| Antianxiety Agents |
1
3.3%
|
2
2.3%
|
| Anticoagulants |
0
0%
|
4
4.5%
|
| Anticonvulsants NEC |
3
10%
|
12
13.6%
|
| Antidepressants NEC |
1
3.3%
|
10
11.4%
|
| Antidiuretics |
1
3.3%
|
0
0%
|
| Antiemetics NEC |
2
6.7%
|
4
4.5%
|
| Antifungal Agents |
0
0%
|
1
1.1%
|
| Antiglaucoma Agents |
0
0%
|
1
1.1%
|
| Antigout Agents |
0
0%
|
5
5.7%
|
| Antihistamines |
19
63.3%
|
57
64.8%
|
| Antihypertensive Agents NEC |
2
6.7%
|
9
10.2%
|
| Antimalarial Agents |
0
0%
|
1
1.1%
|
| Antimetabolites |
0
0%
|
2
2.3%
|
| Antimicrobial/Other Drug Combinations |
0
0%
|
1
1.1%
|
| Antiparkinsonism Agents NEC |
0
0%
|
1
1.1%
|
| Antipsychotic and Antimanic Agents |
3
10%
|
3
3.4%
|
| Antispasmodics and Anticholinergics |
5
16.7%
|
1
1.1%
|
| Antitrichomonal Agents |
1
3.3%
|
1
1.1%
|
| Antiviral Agents NEC |
0
0%
|
1
1.1%
|
| Benzodiazepines |
9
30%
|
10
11.4%
|
| Beta-adrenoceptor Blocking Agents |
2
6.7%
|
4
4.5%
|
| Biguanides |
1
3.3%
|
5
5.7%
|
| Bisphosphonates |
1
3.3%
|
3
3.4%
|
| Bronchodilators and Antiasthmatics |
27
90%
|
70
79.5%
|
| Calcium Channel Blocking Agents |
6
20%
|
12
13.6%
|
| Calcium Compounds and Regulators |
4
13.3%
|
7
8%
|
| Cephalosporin Antibiotics |
0
0%
|
1
1.1%
|
| Cold and Sinus Remedies |
1
3.3%
|
3
3.4%
|
| Cough Preparations |
0
0%
|
5
5.7%
|
| Cox-2 Inhibitors |
1
3.3%
|
2
2.3%
|
| Dermatologic Agents |
1
3.3%
|
2
2.3%
|
| Diuretics NEC |
0
0%
|
6
6.8%
|
| Dopaminergic Agents |
2
6.7%
|
0
0%
|
| Enzymes |
0
0%
|
1
1.1%
|
| Fibrates |
0
0%
|
2
2.3%
|
| Folic Acid and Derivatives |
1
3.3%
|
2
2.3%
|
| Herbal,Homeopathic,& Dietary Supplements |
4
13.3%
|
16
18.2%
|
| Histamine H2-receptor Antagonists |
5
16.7%
|
6
6.8%
|
| Hypertensives |
1
3.3%
|
0
0%
|
| Hypoglycemics NEC |
1
3.3%
|
3
3.4%
|
| Immunosuppressants |
1
3.3%
|
2
2.3%
|
| Insulins |
0
0%
|
2
2.3%
|
| Laxatives and Stool Softeners |
1
3.3%
|
3
3.4%
|
| Leukotriene Receptor Antagonists |
19
63.3%
|
49
55.7%
|
| Lipid Regulating Agents NEC |
0
0%
|
2
2.3%
|
| Local Anesthetics |
1
3.3%
|
0
0%
|
| Loop Diuretics |
2
6.7%
|
9
10.2%
|
| Macrolide Antibiotics |
3
10%
|
2
2.3%
|
| Miscellaneous Cardiovascular Agents |
0
0%
|
1
1.1%
|
| Miscellaneous Drugs |
0
0%
|
1
1.1%
|
| Mucosal Protectants |
1
3.3%
|
0
0%
|
| Muscle Relaxants |
2
6.7%
|
6
6.8%
|
| Nitrofurans |
0
0%
|
1
1.1%
|
| Non Drug Therapies |
1
3.3%
|
1
1.1%
|
| Non-steroidal Anti-inflammatories |
6
20%
|
9
10.2%
|
| Opioid Analgesics |
2
6.7%
|
6
6.8%
|
| Parasympathomimetics and Antimyasthenics |
1
3.3%
|
0
0%
|
| Penicillins |
1
3.3%
|
2
2.3%
|
| Peripheral and Cerebral Vascular Agents |
1
3.3%
|
0
0%
|
| Pharmaceutic Aids |
1
3.3%
|
2
2.3%
|
| Pharmacotherapeutic Class (ES) Not Known |
0
0%
|
3
3.4%
|
| Phenothiazines |
1
3.3%
|
0
0%
|
| Platelet Aggregation Inhibitors |
0
0%
|
3
3.4%
|
| Proton Pump Inhibitors |
13
43.3%
|
36
40.9%
|
| Quinolone Antibiotics |
0
0%
|
3
3.4%
|
| Salicylates |
4
13.3%
|
12
13.6%
|
| Sedatives and Hypnotics |
2
6.7%
|
5
5.7%
|
| Selective Serotonin Re-uptake Inhibitors |
8
26.7%
|
15
17%
|
| Sex Hormones |
8
26.7%
|
14
15.9%
|
| Statins |
3
10%
|
20
22.7%
|
| Steroid/Other Drug Combinations |
0
0%
|
3
3.4%
|
| Steroids |
24
80%
|
53
60.2%
|
| Sulfonylureas |
2
6.7%
|
1
1.1%
|
| Supplements |
1
3.3%
|
12
13.6%
|
| Tetracyclines |
1
3.3%
|
0
0%
|
| Therapeutic Gases |
2
6.7%
|
2
2.3%
|
| Thiazide Diuretics |
3
10%
|
3
3.4%
|
| Thiazolidinediones |
0
0%
|
2
2.3%
|
| Thyroid Hormones |
5
16.7%
|
12
13.6%
|
| Tricyclic Antidepressants |
3
10%
|
4
4.5%
|
| Vaccines, Toxoids and Serologic Agents |
1
3.3%
|
1
1.1%
|
| Vitamins and Minerals |
9
30%
|
24
27.3%
|
| Title | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. |
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 21 | 10 |
| Participants with Positive IgG ATA |
0
0%
|
0
0%
|
| Participants with Negative IgG ATA |
21
70%
|
10
11.4%
|
| Participants with Positive IgE ATA |
0
0%
|
0
0%
|
| Participants with Negative IgE ATA |
21
70%
|
10
11.4%
|
| Title | Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy |
|---|---|
| Description | |
| Time Frame | Substudy Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded. |
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 3 | 7 |
| Number [participants] |
0
0%
|
2
2.3%
|
| Title | Number of Participants With ATA - Skin Testing Substudy |
|---|---|
| Description | Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported. |
| Time Frame | Substudy Week 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. |
| Arm/Group Title | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 3 | 6 |
| Participants with Positive IgG ATA |
0
0%
|
0
0%
|
| Participants with Negative IgG ATA |
3
10%
|
6
6.8%
|
| Participants with Positive IgE ATA |
0
0%
|
0
0%
|
| Participants with Negative IgE ATA |
3
10%
|
6
6.8%
|
Adverse Events
| Time Frame | Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||||
| Arm/Group Title | Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis | ||||
| Arm/Group Description | 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. | 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. | 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. | 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. | ||||
All Cause Mortality |
||||||||
| Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/88 (0%) | 1/3 (33.3%) | 0/7 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Status asthmaticus | 0/30 (0%) | 0/88 (0%) | 1/3 (33.3%) | 0/7 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/88 (0%) | 1/3 (33.3%) | 1/7 (14.3%) | ||||
| Nervous system disorders | ||||||||
| Headache | 0/30 (0%) | 0/88 (0%) | 1/3 (33.3%) | 0/7 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/30 (0%) | 0/88 (0%) | 0/3 (0%) | 1/7 (14.3%) | ||||
Limitations/Caveats
Endpoint prioritization was not specified in study protocol; hence, all endpoints are reported as primary.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00813748
Other Study ID Numbers:
- Q4458g
First Posted:
Dec 23, 2008
Last Update Posted:
Jul 11, 2017
Last Verified:
Jun 1, 2017