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 NCT02563067)

Last Updated: 2021-05-03

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

877 participants

Primary outcome timeframe

52 weeks

Results posted on

2021-05-03

Participant Flow

Participants were recruited from centers in Argentina (18), Canada (5), Czech Republic (7), Greece (6), India (12), Israel (5), Italy (22), Japan (16), Lebanon (3), Malaysia (4), Mexico (3), Netherlands (4), Russian Federation (11), Serbia (4), Slovakia (11), South Africa (3), Spain (13), Taiwan (3) and the United States (19).

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	296	294	287
Overall Study FAS/SAF: High Eosinophils Subpopulation	198	196	193
Overall Study FAS/SAF: Overall Population	296	293	287
Overall Study COMPLETED	277	268	267
Overall Study NOT COMPLETED	19	26	20

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 Subject/guardian decision	14	20	16
Overall Study Physician Decision	0	1	3
Overall Study Lost to Follow-up	1	2	0
Overall Study Technical problems	0	1	0
Overall Study Lack of Efficacy	1	0	0
Overall Study Death	0	1	1
Overall Study Adverse Event	2	1	0
Overall Study Death post Treatment/safety period	1	0	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=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=294 Participants QAW039 450 mg once daily	Placebo n=287 Participants Placebo once daily	Total n=877 Participants Total of all reporting groups
Age, Continuous	49.8 years STANDARD_DEVIATION 14.60 • n=5 Participants	49.6 years STANDARD_DEVIATION 15.25 • n=7 Participants	50.9 years STANDARD_DEVIATION 14.16 • n=5 Participants	50.1 years STANDARD_DEVIATION 14.68 • n=4 Participants
Sex: Female, Male Female	165 Participants n=5 Participants	178 Participants n=7 Participants	177 Participants n=5 Participants	520 Participants n=4 Participants
Sex: Female, Male Male	131 Participants n=5 Participants	116 Participants n=7 Participants	110 Participants n=5 Participants	357 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	234 Participants n=5 Participants	235 Participants n=7 Participants	227 Participants n=5 Participants	696 Participants n=4 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Asian	44 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants	126 Participants n=4 Participants
Race/Ethnicity, Customized Native American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: 52 weeks

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

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=198 Participants QAW039 150 mg once daily	QAW039 450 mg n=196 Participants QAW039 450 mg once daily	Placebo n=193 Participants Placebo once daily
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation	0.73 Events/year Interval 0.57 to 0.94	0.76 Events/year Interval 0.59 to 0.99	1.06 Events/year Interval 0.84 to 1.33

PRIMARY outcome

Timeframe: 52 weeks

Population: Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=287 Participants Placebo once daily
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population	0.76 Events/year Interval 0.62 to 0.92	0.70 Events/year Interval 0.57 to 0.87	0.93 Events/year Interval 0.76 to 1.12

SECONDARY outcome

Timeframe: Baseline, Week 52

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

AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. 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=198 Participants QAW039 150 mg once daily	QAW039 450 mg n=196 Participants QAW039 450 mg once daily	Placebo n=193 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	0.73 units on a scale Standard Error 0.061	0.71 units on a scale Standard Error 0.062	0.58 units on a scale Standard Error 0.062

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. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. 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=198 Participants QAW039 150 mg once daily	QAW039 450 mg n=196 Participants QAW039 450 mg once daily	Placebo n=193 Participants Placebo once daily
Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation	-0.92 units on a scale Standard Error 0.067	-0.84 units on a scale Standard Error 0.068	-0.75 units on a scale Standard Error 0.069

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=198 Participants QAW039 150 mg once daily	QAW039 450 mg n=196 Participants QAW039 450 mg once daily	Placebo n=193 Participants Placebo once daily
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation	0.192 Liter Standard Error 0.0306	0.162 Liter Standard Error 0.0311	0.124 Liter Standard Error 0.0313

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=287 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	0.62 units on a scale Standard Error 0.050	0.67 units on a scale Standard Error 0.050	0.55 units on a scale Standard Error 0.051

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=287 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 a scale Standard Error 0.055	-0.77 units on a scale Standard Error 0.055	-0.70 units on a scale Standard Error 0.055

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=287 Participants Placebo once daily
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population	0.153 Liter Standard Error 0.0247	0.164 Liter Standard Error 0.0249	0.103 Liter Standard Error 0.0250

POST_HOC outcome

Timeframe: up to 56 weeks

Population: Safety Set (SAF), including all randomized patients who received at least one dose of study drug

Total Deaths are presented from first dose of study treatment until discontinuation of trial, up to maximum duration of 56 weeks. Deaths on-treatment are presented from first dose of study treatment until last dose of study treatment plus 30 days, up to maximum duration of 56 weeks.

Outcome measures

Outcome measures
Measure	QAW039 150 mg n=296 Participants QAW039 150 mg once daily	QAW039 450 mg n=293 Participants QAW039 450 mg once daily	Placebo n=287 Participants Placebo once daily
All Collected Deaths Total Deaths	1 Participants	1 Participants	1 Participants
All Collected Deaths Deaths on-treatment	0 Participants	1 Participants	1 Participants

Adverse Events

QAW039 150 mg

Serious events: 20 serious events

Other events: 181 other events

Deaths: 0 deaths

QAW039 450 mg

Serious events: 20 serious events

Other events: 183 other events

Deaths: 1 deaths

Placebo

Serious events: 18 serious events

Other events: 180 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	QAW039 150 mg n=296 participants at risk QAW039 150 mg	QAW039 450 mg n=293 participants at risk QAW039 450 mg	Placebo n=287 participants at risk Placebo
Infections and infestations Bronchitis	12.5% 37/296 • 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.	10.2% 30/293 • 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.	11.1% 32/287 • 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 Influenza	5.7% 17/296 • 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.	6.1% 18/293 • 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.	4.5% 13/287 • 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	11.1% 33/296 • 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.	14.3% 42/293 • 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.	9.1% 26/287 • 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	3.4% 10/296 • 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.	4.5% 13/287 • 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	6.1% 18/296 • 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.	4.9% 14/287 • 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	3.4% 10/296 • 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.	2.7% 8/293 • 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.	4.9% 14/287 • 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	6.8% 20/296 • 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.	9.6% 28/293 • 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.	8.4% 24/287 • 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	4.4% 13/296 • 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.	3.1% 9/287 • 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	6.4% 19/296 • 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.	7.2% 21/293 • 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.	3.1% 9/287 • 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	43.6% 129/296 • 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.	40.6% 119/293 • 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.	50.5% 145/287 • 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 Rhinitis allergic	4.4% 13/296 • 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.	2.7% 8/293 • 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.	3.1% 9/287 • 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