| Primary | Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
| | | Title | Denominators | Categories |
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| Cutaneous/Subcutaneous/Mucosal + R | | | | Cutaneous/Subcutaneous/Mucosal + R + CV | | | | Cutaneous/Subcutaneous/Mucosal + R + GIT | | |
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| Primary | Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | | All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. | Posted | | Median | Full Range | minutes | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants | Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants | | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants | | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
|---|
| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants | | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
|---|
| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. |
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| Primary | Medications Within Two Weeks Prior to Blood Draw | Number of participants in each medication class is reported. Participants could have received more than 1 medication class. | All enrolled participants. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. | | OG001 | 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. |
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| Primary | Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported. | All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. | Posted | | Number | | participants | | Baseline (Enrollment Visit) | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. | | OG001 | 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. |
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| Primary | Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy | | Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded. | Posted | | Number | | participants | | Substudy Day 1 | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. | | OG001 | 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. |
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| Primary | Number of Participants With ATA - Skin Testing Substudy | Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported. | Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome. | Posted | | Number | | participants | | Substudy Week 10 | | | | ID | Title | Description |
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| OG000 | Omalizumab Cases | Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria. | | OG001 | 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. |
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