A Study in Participants With Asthma Initiating Treatment... | NCT01922037

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants With Allergic Asthma	Experimental	Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.	Drug: Omalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.	Participants With Allergic Asthma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Number of Asthma Exacerbations During Months 1-12	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.	Months 1-12

Secondary Outcomes

Measure	Description	Time Frame
Total Number of Asthma Exacerbations During Months 1-6	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.	Months 1-6
Total Number of Asthma Exacerbations During Months 7-12

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Allergy & Asthma		Birmingham	Alabama	35209	United States
Achieve Clinical Research, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39309477	Derived	Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024.
38253245	Derived	Chase NM, Littlejohn M, Holweg CTJ, Millette LA, Seetasith A, Steinke JW, Trzaskoma BL, Hanania NA, Casale TB. Effectiveness of omalizumab across different dosing regimens in patients with moderate-to-severe allergic asthma. Respir Med. 2024 Mar;223:107537. doi: 10.1016/j.rmed.2024.107537. Epub 2024 Jan 20.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
BG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.46± 0.815 OG0010.81± 1.407 OG0020.78± 1.369

Secondary

Total Number of Asthma Exacerbations During Months 1-6

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma exacerbations

Months 1-6

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma Exacerbations During Months 7-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma exacerbations

Months 7-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Hospital Admissions During Months 1-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related hospital admissions

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Hospital Admissions During Months 1-6

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related hospital admissions

Months 1-6

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Hospital Admissions During Months 7-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related hospital admissions

Months 7-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related ER Visits During Months 1-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related ER visits

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related ER visits

Months 1-6

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related ER Visits During Months 7-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related ER visits

Months 7-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related physician's office visits

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related physician's office visits

Months 1-6

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related physician's office visits

Months 7-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related telephone calls

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related telephone calls

Months 1-6

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

asthma-related telephone calls

Months 7-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Percentage of Participants by Number of Asthma Exacerbations

Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma

Secondary

Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids

Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

Months 1-12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002

Secondary

Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)

FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Posted

Mean

Standard Deviation

liters

Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma

Secondary

Change From Baseline in Raw Forced Vital Capacity (FVC)

FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.

Posted

Mean

Standard Deviation

liters

Baseline, Month 6, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002	Total Participants With Allergic Asthma

Secondary

Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)

FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.

Posted

Mean

Standard Deviation

liters per second

Baseline, Month 6, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002

Secondary

Change From Baseline in Percentage Predicted FEV1 (ppFEV1)

FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.

Posted

Mean

Standard Deviation

percentage of predicted FEV1

Baseline, Month 6, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Percentage of Participants With Prior Asthma Medications by Category or Class of Medications

Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.

All enrolled participants.

Posted

Number

percentage of participants

Baseline

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications

Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.

All enrolled participants.

Posted

Number

percentage of participants

Baseline until EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG002

Secondary

Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score

AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Month 6, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Change From Baseline in Asthma Control Test (ACT) Overall Score

Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Months 3, 6, 9, 12

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score

WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Month 6, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)

Secondary

Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator

Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant

All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Posted

Number

percentage of participants

EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.

Secondary

Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score

The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.

Posted

Mean

Standard Deviation

units on a scale

Baseline, EOS/ET (up to Month 12)

ID	Title	Description
OG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
OG001	Participants With Allergic Asthma (Age >/=18 Years)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Participants With Allergic Asthma (Age 12-17 Years)	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	5	69	9	69
EG001	Participants With Allergic Asthma (Age >/=18 Years)	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	85	732	58	732
EG002	Total Participants With Allergic Asthma	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	90	801	67	801

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute left ventricular failure	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Chest pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Allergic granulomatous angiitis	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG00111 affected732 at risk EG00211 affected801 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Influenza	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0011 affected732 at risk EG0022 affected801 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Bacteraemia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Helicobacter test positive	Investigations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Malignant glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Headache	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Hemiparesis	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Migraine	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected69 at risk EG00123 affected732 at risk EG00226 affected801 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0014 affected732 at risk EG0024 affected801 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0013 affected732 at risk EG0023 affected801 at risk
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0013 affected732 at risk EG0023 affected801 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Mastectomy	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Muscle operation	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Embolism	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Peripheral embolism	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypothyroidism	Endocrine disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Chest discomfort	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Injection site reaction	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Fatigue	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Influenza like illness	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Injection site pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Injection site pruritus	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Injection site swelling	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Local reaction	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Pain	General disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Serum sickness	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Acute sinusitis	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Influenza	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Mononucleosis syndrome	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0010 affected732 at risk EG0021 affected801 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Headache	Nervous system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0003 affected69 at risk EG0016 affected732 at risk EG0029 affected801 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0001 affected69 at risk EG0011 affected732 at risk EG0022 affected801 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0013 affected732 at risk EG0023 affected801 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0012 affected732 at risk EG0022 affected801 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Urticaria chronic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Foot operation	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Hernia hiatus repair	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Meningioma surgery	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Skin graft	Surgical and medical procedures	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Flushing	Vascular disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0011 affected732 at risk EG0021 affected801 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 19.0	Non-systematic Assessment	EG0000 affected69 at risk EG0013 affected732 at risk EG0023 affected801 at risk

This study was designed as an observational registry of participants with allergic asthma; but, was later reclassified as an interventional trial because the protocol was amended to include blood draws that were not considered to be standard of care.

Certain Agreements

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D012712	Serum Globulins
D005916	Globulins