Trial Outcomes & Findings for Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment. (NCT NCT02555683)

Last Updated: 2020-05-18

Results Overview

A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

894 participants

Primary outcome timeframe

Baseline, Week 52

Results posted on

2020-05-18

Participant Flow

Participants were from Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Latvia, Lithuania, Philippines, Poland, Romania, Singapore, Spain, Switzerland, UK, US, Vietnam.

The study included a Screening period of up to 2 weeks and a Placebo Run-in period of 2 to 6 weeks, during which eligibility for randomization was determined.

Participant milestones

Participant milestones
Measure	QAW039 150 mg QAW039 150 mg once daily	QAW039 450 mg QAW039 450 mg once daily	Placebo Placebo once daily
Overall Study STARTED	301	295	298
Overall Study FAS/SAF: High Eosinophil Subpopulation	200	201	201
Overall Study FAS/SAF: Overall Population	299	293	298
Overall Study COMPLETED	282	278	269
Overall Study NOT COMPLETED	19	17	29

Reasons for withdrawal

Reasons for withdrawal
Measure	QAW039 150 mg QAW039 150 mg once daily	QAW039 450 mg QAW039 450 mg once daily	Placebo Placebo once daily
Overall Study Physician Decision	1	0	2
Overall Study Lost to Follow-up	2	1	2
Overall Study Technical Problems	1	1	0
Overall Study Protocol deviation	0	1	0
Overall Study Lack of Efficacy	2	0	0
Overall Study Death	0	1	2
Overall Study Adverse Event	1	0	1
Overall Study Subject/guardian decision	12	12	22
Overall Study Death post Treatment/safety period	0	1	0

Baseline Characteristics

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QAW039 150 mg n=301 Participants QAW039 150 mg once daily	QAW039 450 mg n=295 Participants QAW039 450 mg once daily	Placebo n=298 Participants Placebo once daily	Total n=894 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 14.97 • n=5 Participants	51.1 years STANDARD_DEVIATION 14.29 • n=7 Participants	50.3 years STANDARD_DEVIATION 14.48 • n=5 Participants	50.4 years STANDARD_DEVIATION 14.58 • n=4 Participants
Sex: Female, Male Female	192 Participants n=5 Participants	214 Participants n=7 Participants	177 Participants n=5 Participants	583 Participants n=4 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	81 Participants n=7 Participants	121 Participants n=5 Participants	311 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	214 Participants n=5 Participants	215 Participants n=7 Participants	213 Participants n=5 Participants	642 Participants n=4 Participants
Race/Ethnicity, Customized Black	11 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Asian	45 Participants n=5 Participants	38 Participants n=7 Participants	44 Participants n=5 Participants	127 Participants n=4 Participants
Race/Ethnicity, Customized Native American	24 Participants n=5 Participants	29 Participants n=7 Participants	24 Participants n=5 Participants	77 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL)

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=200 Participants QAW039 150 mg once daily	QAW039 450 mg n=201 Participants QAW039 450 mg once daily	Placebo n=201 Participants Placebo once daily
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation	0.97 events/year Interval 0.78 to 1.2	0.77 events/year Interval 0.62 to 0.97	0.93 events/year Interval 0.75 to 1.16

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in overall population

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=299 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=298 Participants Placebo once daily
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population	0.92 events/year Interval 0.77 to 1.09	0.75 events/year Interval 0.62 to 0.9	0.96 events/year Interval 0.8 to 1.15

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL)

The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=200 Participants QAW039 150 mg once daily	QAW039 450 mg n=201 Participants QAW039 450 mg once daily	Placebo n=201 Participants Placebo once daily
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation	0.75 units on scale Standard Error 0.067	0.81 units on scale Standard Error 0.067	0.68 units on scale Standard Error 0.067

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL)

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=200 Participants QAW039 150 mg once daily	QAW039 450 mg n=201 Participants QAW039 450 mg once daily	Placebo n=201 Participants Placebo once daily
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation	-0.88 units on scale Standard Error 0.069	-0.94 units on scale Standard Error 0.069	-0.76 units on scale Standard Error 0.070

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL)

Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=200 Participants QAW039 150 mg once daily	QAW039 450 mg n=201 Participants QAW039 450 mg once daily	Placebo n=201 Participants Placebo once daily
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation	0.169 Liter Standard Error 0.0257	0.153 Liter Standard Error 0.0255	0.103 Liter Standard Error 0.0260

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in overall population

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=299 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=298 Participants Placebo once daily
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population	0.68 units on scale Standard Error 0.053	0.73 units on scale Standard Error 0.054	0.61 units on scale Standard Error 0.054

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) overall population

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=299 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=298 Participants Placebo once daily
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population	-0.83 units on scale Standard Error 0.055	-0.90 units on scale Standard Error 0.056	-0.71 units on scale Standard Error 0.056

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS) in overall population

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=299 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=298 Participants Placebo once daily
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population	0.144 Liter Standard Error 0.0205	0.108 Liter Standard Error 0.0206	0.068 Liter Standard Error 0.0209

Adverse Events

QAW039 150 mg

Serious events: 33 serious events

Other events: 204 other events

Deaths: 0 deaths

QAW039 450 mg

Serious events: 30 serious events

Other events: 193 other events

Deaths: 1 deaths

Placebo

Serious events: 32 serious events

Other events: 214 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	QAW039 150 mg n=299 participants at risk QAW039 150 mg	QAW039 450 mg n=293 participants at risk QAW039 450 mg	Placebo n=298 participants at risk Placebo
Infections and infestations Bronchitis	9.7% 29/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	7.5% 22/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	8.7% 26/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Lower respiratory tract infection	4.0% 12/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	3.4% 10/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	2.3% 7/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Nasopharyngitis	14.4% 43/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	12.6% 37/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	16.4% 49/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Rhinitis	2.7% 8/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	3.8% 11/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	4.0% 12/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Sinusitis	6.0% 18/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	6.5% 19/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	6.0% 18/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Upper respiratory tract infection	11.7% 35/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	11.9% 35/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	10.4% 31/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Upper respiratory tract infection bacterial	4.3% 13/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	4.8% 14/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	7.0% 21/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Urinary tract infection	3.7% 11/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	5.1% 15/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	6.0% 18/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Infections and infestations Viral upper respiratory tract infection	9.7% 29/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	8.9% 26/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	8.7% 26/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Investigations Blood creatinine increased	4.3% 13/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	3.8% 11/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	3.0% 9/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	5.4% 16/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	5.5% 16/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	3.7% 11/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Nervous system disorders Headache	9.4% 28/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	7.5% 22/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	8.1% 24/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	50.5% 151/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	46.1% 135/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	52.0% 155/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 11/299 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	1.7% 5/293 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.	4.4% 13/298 • Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks. Any sign or symptom that occurs during the study treatment plus 7 days post treatment for adverse events and 30 days post treatment for serious adverse events.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER