Trial Outcomes & Findings for Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation. (NCT NCT00500539)

Last Updated: 2011-06-02

Results Overview

An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

155 participants

Primary outcome timeframe

16 weeks after last dose

Results posted on

2011-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Omalizumab The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Treatment Period (24 Weeks) STARTED	155
Treatment Period (24 Weeks) COMPLETED	140
Treatment Period (24 Weeks) NOT COMPLETED	15
Follow-up Period (16 Weeks) STARTED	148
Follow-up Period (16 Weeks) COMPLETED	136
Follow-up Period (16 Weeks) NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Treatment Period (24 Weeks) Adverse Event	4
Treatment Period (24 Weeks) Unsatisfactory therapeutic effect	1
Treatment Period (24 Weeks) Subject withdrew consent	1
Treatment Period (24 Weeks) Lost to Follow-up	2
Treatment Period (24 Weeks) Administrative problems	2
Treatment Period (24 Weeks) Protocol Deviation	5
Follow-up Period (16 Weeks) Adverse Event	1
Follow-up Period (16 Weeks) Subject withdrew consent	2
Follow-up Period (16 Weeks) Lost to Follow-up	3
Follow-up Period (16 Weeks) Administrative problems	1
Follow-up Period (16 Weeks) Death	1
Follow-up Period (16 Weeks) Protocol Deviation	1
Follow-up Period (16 Weeks) Missing	3

Baseline Characteristics

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab n=155 Participants The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Age, Categorical <=18 years	13 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	135 Participants n=99 Participants
Age, Categorical >=65 years	7 Participants n=99 Participants
Age Continuous	42.7 years STANDARD_DEVIATION 14.32 • n=99 Participants
Sex: Female, Male Female	95 Participants n=99 Participants
Sex: Female, Male Male	60 Participants n=99 Participants

PRIMARY outcome

Timeframe: 16 weeks after last dose

Population: The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.

Outcome measures

Outcome measures
Measure	Follow-up Period n=136 Participants Participants were assessed at 16 weeks after the last dose of study drug
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fab HAHA Positive - Negative at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fab HAHA Positive - Positive at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fab HAHA Positive - Missing at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fc HAHA Positive - Negative at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fc HAHA Positive - Positive at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fc HAHA Positive - Missing at baseline	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Fab and/or Fc HAHA Positive - Fab and Fc HAHA -Ve	0 participants
The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period Missing at baseline	0 participants

SECONDARY outcome

Timeframe: 24 weeks treatment period + 4 weeks for following up participants

Population: The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.

The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.

Outcome measures

Outcome measures
Measure	Follow-up Period n=155 Participants Participants were assessed at 16 weeks after the last dose of study drug
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Participants with AEs during the treatment period	124 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Mild AEs	25 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Moderate AEs	76 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Severe AEs	23 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period AEs suspected to be related to study drug	22 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period AEs not suspected to be related to study drug	102 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Deaths	1 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Serious Adverse Events (SAEs)	14 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Discontinued due to Adverse Events	4 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Discontinued due to Serious Adverse Events	2 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period Discontinued due to non-serious Adverse Events	2 participants

SECONDARY outcome

Timeframe: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)

Population: The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.

The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).

Outcome measures

Outcome measures
Measure	Follow-up Period n=148 Participants Participants were assessed at 16 weeks after the last dose of study drug
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Participants with AEs during the follow-up period	51 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Mild AEs	11 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Moderate AEs	37 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Severe AEs	3 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period AEs suspected to be related to study drug	0 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period AEs not suspected to be related to study drug	51 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Deaths	0 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Serious adverse events (SAEs)	1 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Discontinued due to Adverse Events	1 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Discontinued due to Serious Adverse Events	0 participants
Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period Discontinued due to non-serious Adverse Events	1 participants

Adverse Events

Omalizumab Treatment Period

Serious events: 14 serious events

Other events: 74 other events

Deaths: 0 deaths

Omalizumab Follow up Period

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Omalizumab Treatment Period n=155 participants at risk The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.	Omalizumab Follow up Period n=148 participants at risk Participants were assessed at 16 weeks after the last dose of study drug
Infections and infestations Gastroenteritis viral	5.2% 8/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Infections and infestations Nasopharyngitis	9.7% 15/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	2.0% 3/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Infections and infestations Sinusitis	17.4% 27/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	8.1% 12/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Infections and infestations Upper respiratory tract infection	11.6% 18/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	4.1% 6/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Nervous system disorders Headache	8.4% 13/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.68% 1/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Respiratory, thoracic and mediastinal disorders Asthma	15.5% 24/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	10.8% 16/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 9/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.68% 1/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Measure	Omalizumab Treatment Period n=155 participants at risk The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.	Omalizumab Follow up Period n=148 participants at risk Participants were assessed at 16 weeks after the last dose of study drug
Blood and lymphatic system disorders Anaemia	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Cardiac disorders Angina unstable	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Cardiac disorders Cardiac arrest	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Gastrointestinal disorders Enteritis	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Gastrointestinal disorders Gastric ulcer	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Infections and infestations Bronchiectasis	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Infections and infestations Pneumonia	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Injury, poisoning and procedural complications Cartilage injury	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Injury, poisoning and procedural complications Post procedural swelling	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Metabolism and nutrition disorders Dehydration	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Nervous system disorders Epilepsy	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.68% 1/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Respiratory, thoracic and mediastinal disorders Asthma	2.6% 4/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.65% 1/155 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.	0.00% 0/148 • Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total). The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.