Trial Outcomes & Findings for A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair) (NCT NCT01922037)

NCT ID: NCT01922037

Last Updated: 2017-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

806 participants

Primary outcome timeframe

Months 1-12

Results posted on

2017-12-11

Participant Flow

Results are reported by age group (adult participants and adolescent participants) as well as for all participants.

Participant milestones

Participant milestones
Measure	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.	Participants With Allergic Asthma (Age >/=18 Years) Adult participants (age greater than or equal to \[\>/=18\] 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.
Overall Study STARTED	69	737
Overall Study Treated	69	732
Overall Study COMPLETED	59	563
Overall Study NOT COMPLETED	10	174

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Participants With Allergic Asthma (Age >/=18 Years) Adult participants (age greater than or equal to \[\>/=18\] 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.
Overall Study Withdrawal by Subject	2	44
Overall Study Adverse Event	1	7
Overall Study Death	0	5
Overall Study Pregnancy	0	2
Overall Study Participant non-compliance	4	46
Overall Study Investigator/Sponsor decision	1	4
Overall Study Other unspecified	2	66

Baseline Characteristics

All enrolled participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=737 Participants 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.	Total n=806 Participants Total of all reporting groups
Age, Continuous	14.0 years STANDARD_DEVIATION 1.69 • n=5 Participants	50.4 years STANDARD_DEVIATION 14.75 • n=7 Participants	47.3 years STANDARD_DEVIATION 17.40 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants • All enrolled participants	487 Participants n=7 Participants • All enrolled participants	512 Participants n=5 Participants • All enrolled participants
Sex: Female, Male Male	44 Participants n=5 Participants • All enrolled participants	250 Participants n=7 Participants • All enrolled participants	294 Participants n=5 Participants • All enrolled participants

PRIMARY outcome

Timeframe: Months 1-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Total Number of Asthma Exacerbations During Months 1-12	0.46 asthma exacerbations Standard Deviation 0.815	0.81 asthma exacerbations Standard Deviation 1.407	0.78 asthma exacerbations Standard Deviation 1.369

SECONDARY outcome

Timeframe: Months 1-6

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=726 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Total Number of Asthma Exacerbations During Months 1-6	0.20 asthma exacerbations Standard Deviation 0.440	0.51 asthma exacerbations Standard Deviation 0.988	0.48 asthma exacerbations Standard Deviation 0.957

SECONDARY outcome

Timeframe: Months 7-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=635 Participants 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.	Total Participants With Allergic Asthma n=698 Participants 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.
Total Number of Asthma Exacerbations During Months 7-12	0.29 asthma exacerbations Standard Deviation 0.521	0.35 asthma exacerbations Standard Deviation 0.756	0.35 asthma exacerbations Standard Deviation 0.738

SECONDARY outcome

Timeframe: Months 1-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Total Number of Asthma-Related Hospital Admissions During Months 1-12	0.04 asthma-related hospital admissions Standard Deviation 0.205	0.06 asthma-related hospital admissions Standard Deviation 0.356	0.06 asthma-related hospital admissions Standard Deviation 0.346

SECONDARY outcome

Timeframe: Months 1-6

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=726 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Total Number of Asthma-Related Hospital Admissions During Months 1-6	0.03 asthma-related hospital admissions Standard Deviation 0.169	0.03 asthma-related hospital admissions Standard Deviation 0.230	0.03 asthma-related hospital admissions Standard Deviation 0.225

SECONDARY outcome

Timeframe: Months 7-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=635 Participants 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.	Total Participants With Allergic Asthma n=698 Participants 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.
Total Number of Asthma-Related Hospital Admissions During Months 7-12	0.02 asthma-related hospital admissions Standard Deviation 0.126	0.03 asthma-related hospital admissions Standard Deviation 0.215	0.03 asthma-related hospital admissions Standard Deviation 0.208

SECONDARY outcome

Timeframe: Months 1-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Total Number of Asthma-Related ER Visits During Months 1-12	0.13 asthma-related ER visits Standard Deviation 0.380	0.14 asthma-related ER visits Standard Deviation 0.575	0.14 asthma-related ER visits Standard Deviation 0.560

SECONDARY outcome

Timeframe: Months 1-6

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=726 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6	0.04 asthma-related ER visits Standard Deviation 0.205	0.09 asthma-related ER visits Standard Deviation 0.410	0.09 asthma-related ER visits Standard Deviation 0.397

SECONDARY outcome

Timeframe: Months 7-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=635 Participants 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.	Total Participants With Allergic Asthma n=698 Participants 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.
Total Number of Asthma-Related ER Visits During Months 7-12	0.10 asthma-related ER visits Standard Deviation 0.296	0.06 asthma-related ER visits Standard Deviation 0.293	0.06 asthma-related ER visits Standard Deviation 0.294

SECONDARY outcome

Timeframe: Months 1-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12	0.39 asthma-related physician's office visits Standard Deviation 0.771	0.39 asthma-related physician's office visits Standard Deviation 0.866	0.39 asthma-related physician's office visits Standard Deviation 0.858

SECONDARY outcome

Timeframe: Months 1-6

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=726 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6	0.23 asthma-related physician's office visits Standard Deviation 0.598	0.23 asthma-related physician's office visits Standard Deviation 0.584	0.23 asthma-related physician's office visits Standard Deviation 0.585

SECONDARY outcome

Timeframe: Months 7-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=635 Participants 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.	Total Participants With Allergic Asthma n=698 Participants 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.
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12	0.17 asthma-related physician's office visits Standard Deviation 0.423	0.18 asthma-related physician's office visits Standard Deviation 0.515	0.18 asthma-related physician's office visits Standard Deviation 0.507

SECONDARY outcome

Timeframe: Months 1-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12	0.35 asthma-related telephone calls Standard Deviation 0.783	0.43 asthma-related telephone calls Standard Deviation 1.181	0.43 asthma-related telephone calls Standard Deviation 1.152

SECONDARY outcome

Timeframe: Months 1-6

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=726 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6	0.16 asthma-related telephone calls Standard Deviation 0.407	0.24 asthma-related telephone calls Standard Deviation 0.799	0.23 asthma-related telephone calls Standard Deviation 0.773

SECONDARY outcome

Timeframe: Months 7-12

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=635 Participants 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.	Total Participants With Allergic Asthma n=698 Participants 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.
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12	0.21 asthma-related telephone calls Standard Deviation 0.544	0.22 asthma-related telephone calls Standard Deviation 0.692	0.22 asthma-related telephone calls Standard Deviation 0.680

SECONDARY outcome

Timeframe: Months 1-12

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Percentage of Participants by Number of Asthma Exacerbations No (0) Asthma Exacerbation	69.6 percentage of participants	61.8 percentage of participants	62.4 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations 1 Asthma Exacerbation	18.8 percentage of participants	18.3 percentage of participants	18.3 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations 2 Asthma Exacerbations	7.2 percentage of participants	9.2 percentage of participants	9.0 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations 3 Asthma Exacerbations	4.3 percentage of participants	4.3 percentage of participants	4.3 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations >/=4 Asthma Exacerbations	0 percentage of participants	6.5 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: Months 1-12

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=796 Participants 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.
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids No (0) Asthma Exacerbation Requiring Treatment	71.0 percentage of participants	62.3 percentage of participants	63.1 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids 1 Asthma Exacerbation Requiring Treatment	20.3 percentage of participants	18.2 percentage of participants	18.3 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids 2 Asthma Exacerbations Requiring Treatment	4.3 percentage of participants	9.4 percentage of participants	8.9 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids 3 Asthma Exacerbations Requiring Treatment	4.3 percentage of participants	4.5 percentage of participants	4.5 percentage of participants
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids >/=4 Asthma Exacerbations Requiring Treatment	0 percentage of participants	5.6 percentage of participants	5.2 percentage of participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=67 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=728 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Baseline: Pre-bronchodilator FEV1	2.61 liters Standard Deviation 0.736	2.24 liters Standard Deviation 0.820	2.27 liters Standard Deviation 0.819
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Change at Month 6: Pre-bronchodilator FEV1	0.09 liters Standard Deviation 0.402	0.06 liters Standard Deviation 0.359	0.06 liters Standard Deviation 0.363
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Change at EOS/ET: Pre-bronchodilator FEV1	0.16 liters Standard Deviation 0.463	0.03 liters Standard Deviation 0.378	0.04 liters Standard Deviation 0.388
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Baseline: Post-bronchodilator FEV1	2.79 liters Standard Deviation 0.767	2.38 liters Standard Deviation 0.810	2.41 liters Standard Deviation 0.814
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Change at Month 6: Post-bronchodilator FEV1	0.05 liters Standard Deviation 0.522	0.04 liters Standard Deviation 0.286	0.05 liters Standard Deviation 0.315
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) Change at EOS/ET: Post-bronchodilator FEV1	0.18 liters Standard Deviation 0.446	0.02 liters Standard Deviation 0.322	0.03 liters Standard Deviation 0.338

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=67 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=728 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Change From Baseline in Raw Forced Vital Capacity (FVC) Baseline: Pre-bronchodilator FVC	3.36 liters Standard Deviation 0.842	3.08 liters Standard Deviation 0.987	3.11 liters Standard Deviation 0.978
Change From Baseline in Raw Forced Vital Capacity (FVC) Change at Month 6: Pre-bronchodilator FVC	0.09 liters Standard Deviation 0.380	0.07 liters Standard Deviation 0.562	0.07 liters Standard Deviation 0.548
Change From Baseline in Raw Forced Vital Capacity (FVC) Change at EOS/ET: Pre-bronchodilator FVC	0.22 liters Standard Deviation 0.321	0.03 liters Standard Deviation 0.417	0.04 liters Standard Deviation 0.413
Change From Baseline in Raw Forced Vital Capacity (FVC) Baseline: Post-bronchodilator FVC	3.43 liters Standard Deviation 0.878	3.19 liters Standard Deviation 0.959	3.21 liters Standard Deviation 0.954
Change From Baseline in Raw Forced Vital Capacity (FVC) Change at Month 6: Post-bronchodilator FVC	0.06 liters Standard Deviation 0.324	0.07 liters Standard Deviation 0.661	0.07 liters Standard Deviation 0.637
Change From Baseline in Raw Forced Vital Capacity (FVC) Change at EOS/ET: Post-bronchodilator FVC	0.20 liters Standard Deviation 0.301	0.02 liters Standard Deviation 0.349	0.04 liters Standard Deviation 0.348

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=67 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=727 Participants 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.	Total Participants With Allergic Asthma n=794 Participants 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.
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Baseline:Pre-bronchodilator FEF25%-75%	3.96 liters per second Standard Deviation 12.328	2.28 liters per second Standard Deviation 9.646	2.42 liters per second Standard Deviation 9.902
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Change at Month 6:Pre-bronchodilator FEF25%-75%	-1.66 liters per second Standard Deviation 13.518	-0.44 liters per second Standard Deviation 10.868	-0.55 liters per second Standard Deviation 11.131
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Change at EOS/ET:Pre-bronchodilator FEF25%-75%	-1.69 liters per second Standard Deviation 13.426	-0.47 liters per second Standard Deviation 10.825	-0.58 liters per second Standard Deviation 11.080
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Baseline:Post-bronchodilator FEF25%-75%	3.76 liters per second Standard Deviation 6.676	2.58 liters per second Standard Deviation 9.503	2.68 liters per second Standard Deviation 9.302
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Change at Month 6:Post-bronchodilator FEF25%-75%	-1.00 liters per second Standard Deviation 7.513	-0.59 liters per second Standard Deviation 11.051	-0.63 liters per second Standard Deviation 10.767
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) Change at EOS/ET:Post-bronchodilator FEF25%-75%	-0.76 liters per second Standard Deviation 7.515	-0.61 liters per second Standard Deviation 10.926	-0.62 liters per second Standard Deviation 10.661

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=67 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=728 Participants 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.	Total Participants With Allergic Asthma n=795 Participants 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.
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Baseline: Pre-bronchodilator ppFEV1	87.89 percentage of predicted FEV1 Standard Deviation 16.934	74.23 percentage of predicted FEV1 Standard Deviation 20.569	75.38 percentage of predicted FEV1 Standard Deviation 20.631
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Change at Month 6: Pre-bronchodilator ppFEV1	2.72 percentage of predicted FEV1 Standard Deviation 13.279	1.77 percentage of predicted FEV1 Standard Deviation 12.270	1.86 percentage of predicted FEV1 Standard Deviation 12.359
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Change at EOS/ET: Pre-bronchodilator ppFEV1	6.00 percentage of predicted FEV1 Standard Deviation 14.713	0.91 percentage of predicted FEV1 Standard Deviation 12.922	1.37 percentage of predicted FEV1 Standard Deviation 13.163
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Baseline: Post-bronchodilator ppFEV1	93.61 percentage of predicted FEV1 Standard Deviation 16.416	78.92 percentage of predicted FEV1 Standard Deviation 19.514	80.15 percentage of predicted FEV1 Standard Deviation 19.690
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Change at Month 6: Post-bronchodilator ppFEV1	2.09 percentage of predicted FEV1 Standard Deviation 16.398	1.47 percentage of predicted FEV1 Standard Deviation 9.617	1.52 percentage of predicted FEV1 Standard Deviation 10.421
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) Change at EOS/ET: Post-bronchodilator ppFEV1	7.39 percentage of predicted FEV1 Standard Deviation 14.673	0.82 percentage of predicted FEV1 Standard Deviation 11.099	1.40 percentage of predicted FEV1 Standard Deviation 11.597

SECONDARY outcome

Timeframe: Baseline

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=737 Participants 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.	Total Participants With Allergic Asthma n=806 Participants 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.
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications All types	98.6 percentage of participants	99.3 percentage of participants	99.3 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications SABA	91.3 percentage of participants	88.6 percentage of participants	88.8 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications Combination ICS/LABA	79.7 percentage of participants	84.1 percentage of participants	83.7 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications LTRA	73.9 percentage of participants	66.6 percentage of participants	67.2 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications ICS	36.2 percentage of participants	33.8 percentage of participants	34.0 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications Oral/Parenteral (systemic) corticisteroids	27.5 percentage of participants	31.6 percentage of participants	31.3 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications Anticholinergic	10.1 percentage of participants	28.4 percentage of participants	26.8 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications LABA	1.4 percentage of participants	4.1 percentage of participants	3.8 percentage of participants
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications Other medication	5.8 percentage of participants	5.3 percentage of participants	5.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline until EOS/ET (up to Month 12)

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=737 Participants 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.	Total Participants With Allergic Asthma n=806 Participants 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.
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications LABA	1.4 percentage of participants	4.5 percentage of participants	4.2 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications All types	100.0 percentage of participants	99.2 percentage of participants	99.3 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications SABA	91.3 percentage of participants	89.4 percentage of participants	89.6 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications Combination ICS/LABA	82.6 percentage of participants	82.4 percentage of participants	82.4 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications LTRA	69.6 percentage of participants	63.9 percentage of participants	64.4 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications Oral/Parenteral (systemic) corticosteroids	37.7 percentage of participants	47.2 percentage of participants	46.4 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications ICS	33.3 percentage of participants	34.3 percentage of participants	34.2 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications Anticholinergic	11.6 percentage of participants	32.6 percentage of participants	30.8 percentage of participants
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications Other medication	7.2 percentage of participants	9.9 percentage of participants	9.7 percentage of participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=732 Participants 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.	Total Participants With Allergic Asthma n=801 Participants 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.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score Baseline	4.71 units on a scale Standard Deviation 1.332	3.93 units on a scale Standard Deviation 1.348	4.00 units on a scale Standard Deviation 1.363
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score Change at Month 6	0.94 units on a scale Standard Deviation 1.134	1.18 units on a scale Standard Deviation 1.223	1.16 units on a scale Standard Deviation 1.216
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score Change at EOS/ET	1.11 units on a scale Standard Deviation 1.174	1.33 units on a scale Standard Deviation 1.267	1.31 units on a scale Standard Deviation 1.259

SECONDARY outcome

Timeframe: Baseline, Months 3, 6, 9, 12

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=68 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=732 Participants 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.	Total Participants With Allergic Asthma n=800 Participants 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.
Change From Baseline in Asthma Control Test (ACT) Overall Score Baseline	16.40 units on a scale Standard Deviation 5.117	13.71 units on a scale Standard Deviation 4.910	13.94 units on a scale Standard Deviation 4.981
Change From Baseline in Asthma Control Test (ACT) Overall Score Change at Month 3	3.11 units on a scale Standard Deviation 4.141	3.58 units on a scale Standard Deviation 4.263	3.54 units on a scale Standard Deviation 4.252
Change From Baseline in Asthma Control Test (ACT) Overall Score Change at Month 6	3.57 units on a scale Standard Deviation 4.339	4.16 units on a scale Standard Deviation 4.677	4.11 units on a scale Standard Deviation 4.649
Change From Baseline in Asthma Control Test (ACT) Overall Score Change at Month 9	3.90 units on a scale Standard Deviation 4.844	4.39 units on a scale Standard Deviation 4.910	4.35 units on a scale Standard Deviation 4.903
Change From Baseline in Asthma Control Test (ACT) Overall Score Change at Month 12	3.90 units on a scale Standard Deviation 4.997	4.48 units on a scale Standard Deviation 4.926	4.43 units on a scale Standard Deviation 4.932

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=67 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=717 Participants 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.	Total Participants With Allergic Asthma n=784 Participants 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.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Overall WI: Change at Month 6	0.00 units on a scale	-15.55 units on a scale Standard Deviation 27.476	-15.49 units on a scale Standard Deviation 27.443
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Activity impairment: Baseline	36.12 units on a scale Standard Deviation 27.577	48.79 units on a scale Standard Deviation 28.749	47.70 units on a scale Standard Deviation 28.893
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Activity impairment: Change at Month 6	-9.12 units on a scale Standard Deviation 33.449	-19.30 units on a scale Standard Deviation 30.445	-18.38 units on a scale Standard Deviation 30.840
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Activity impairment: Change at EOS/ET	-14.83 units on a scale Standard Deviation 31.967	-21.40 units on a scale Standard Deviation 32.424	-20.80 units on a scale Standard Deviation 32.413
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Work time missed: Baseline	10.37 units on a scale Standard Deviation 14.759	7.70 units on a scale Standard Deviation 19.936	7.72 units on a scale Standard Deviation 19.890
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Work time missed: Change at Month 6	0.00 units on a scale	-3.31 units on a scale Standard Deviation 19.796	-3.30 units on a scale Standard Deviation 19.763
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Work time missed: Change at EOS/ET	-27.27 units on a scale	-4.06 units on a scale Standard Deviation 21.977	-4.14 units on a scale Standard Deviation 21.982
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Impairment while working: Baseline	10.00 units on a scale Standard Deviation 14.142	31.36 units on a scale Standard Deviation 27.111	31.15 units on a scale Standard Deviation 27.087
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Impairment while working: Change at Month 6	0.00 units on a scale Standard Deviation 0.000	-16.24 units on a scale Standard Deviation 26.775	-16.13 units on a scale Standard Deviation 26.719
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Impairment while working: Change at EOS/ET	-30.00 units on a scale	-15.93 units on a scale Standard Deviation 27.677	-15.98 units on a scale Standard Deviation 27.643
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Overall WI: Baseline	20.85 units on a scale Standard Deviation 25.366	33.59 units on a scale Standard Deviation 28.737	33.49 units on a scale Standard Deviation 28.705
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score Overall WI: Change at EOS/ET	-49.09 units on a scale	-16.24 units on a scale Standard Deviation 29.578	-16.35 units on a scale Standard Deviation 29.590

SECONDARY outcome

Timeframe: EOS/ET (up to Month 12)

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

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=583 Participants 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.	Total Participants With Allergic Asthma n=646 Participants 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.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator	81.0 percentage of participants	75.8 percentage of participants	76.3 percentage of participants

SECONDARY outcome

Timeframe: EOS/ET (up to Month 12)

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

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=63 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=599 Participants 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.	Total Participants With Allergic Asthma n=662 Participants 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.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant	87.3 percentage of participants	75.0 percentage of participants	76.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, EOS/ET (up to Month 12)

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.

Outcome measures

Outcome measures
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=68 Participants 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.	Participants With Allergic Asthma (Age >/=18 Years) n=732 Participants 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.	Total Participants With Allergic Asthma n=800 Participants 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.
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score Baseline	2.44 units on a scale Standard Deviation 1.435	2.76 units on a scale Standard Deviation 1.375	2.73 units on a scale Standard Deviation 1.382
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score Change at EOS/ET	-1.17 units on a scale Standard Deviation 1.357	-0.99 units on a scale Standard Deviation 1.307	-1.01 units on a scale Standard Deviation 1.311

Adverse Events

Participants With Allergic Asthma (Age 12-17 Years)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Participants With Allergic Asthma (Age >/=18 Years)

Serious events: 85 serious events

Other events: 58 other events

Deaths: 0 deaths

Total Participants With Allergic Asthma

Serious events: 90 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 participants at risk 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.	Participants With Allergic Asthma (Age >/=18 Years) n=732 participants at risk 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.	Total Participants With Allergic Asthma n=801 participants at risk 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.
Cardiac disorders Acute left ventricular failure	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Myocardial infarction	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Angina pectoris	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Arrhythmia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Atrial fibrillation	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Cardiac arrest	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Cardiogenic shock	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Coronary artery thrombosis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Cardiac disorders Ventricular fibrillation	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Abdominal pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Pancreatitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Chest pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Hepatobiliary disorders Cholelithiasis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Immune system disorders Anaphylactic reaction	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Immune system disorders Allergic granulomatous angiitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Pneumonia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	1.5% 11/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	1.4% 11/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Cellulitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Diverticulitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Influenza	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Appendicitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Bacteraemia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Gastrointestinal viral infection	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Osteomyelitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Tubo-ovarian abscess	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Urinary tract infection	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Fall	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Wound	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Investigations Helicobacter test positive	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Dehydration	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Fluid retention	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Intervertebral disc displacement	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant glioma	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.

Other adverse events
Measure	Participants With Allergic Asthma (Age 12-17 Years) n=69 participants at risk 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.	Participants With Allergic Asthma (Age >/=18 Years) n=732 participants at risk 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.	Total Participants With Allergic Asthma n=801 participants at risk 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.
Endocrine disorders Hypothyroidism	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Diarrhoea	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Gastrointestinal disorders Vomiting	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Chest discomfort	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Injection site reaction	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Fatigue	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Influenza like illness	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Injection site pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Injection site pruritus	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Injection site swelling	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Local reaction	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
General disorders Pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Hepatobiliary disorders Cholecystitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Immune system disorders Serum sickness	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Bronchitis	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Pneumonia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.27% 2/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Acute sinusitis	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Influenza	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Mononucleosis syndrome	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Pneumonia mycoplasmal	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Upper respiratory tract infection	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.00% 0/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Infections and infestations Urinary tract infection	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Fall	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Laceration	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Nervous system disorders Dizziness	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Nervous system disorders Headache	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.12% 1/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Respiratory, thoracic and mediastinal disorders Asthma	4.3% 3/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.82% 6/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	1.1% 9/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.
Respiratory, thoracic and mediastinal disorders Wheezing	1.4% 1/69 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.14% 1/732 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.	0.25% 2/801 • From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year) Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.