Asthma
Conditions
Keywords
Asthma, QAW039, allergic asthma, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
Brief summary
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
Detailed description
The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.
Interventions
DRUGQAW039 150 mg
One tablet of QAW039 150 mg once daily
DRUGQAW039 450 mg
One tablet of QAW039 450 mg once daily
DRUGPlacebo
One tablet of Placebo once daily
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients completing a prior Phase 3 study of QAW039: * Informed consent and assent (if applicable). * Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039. * Patient is able to safely continue into the study as judged by the investigator. Patients who have not previously participated in a study of QAW039: * Written informed consent. * A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication. * Evidence of airway reversibility or airway hyper- reactivity. * FEV1 of ≤85% of the predicted normal value. * An ACQ score ≥1.5 prior to entering the study.
Exclusion criteria
Patients completing a prior phase 3 study of QAW039: * Pregnant or nursing (lactating) women. * Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug * Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in. * Inability to comply with all study requirements. * Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in. Patients who have not previously participated in a study of QAW039: * Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer. * Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study). * A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female). * History of malignancy with the exception of local basal cell carcinoma of the skin * Pregnant or nursing (lactating) women. * Serious co-morbidities. * Patients on greater than 20 mg of simvastatin\> 40 mg of atorvastatin, \>40 mg of pravastatin, or \>2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 156 weeks | Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation |
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 52 weeks | Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 156 weeks | Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 52 weeks | Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported. |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 156 weeks | Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. |
| Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 52 weeks | Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | 52 weeks | The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) |
| Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | 156 weeks | The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) |
| Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 52 weeks | The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs. |
| Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 156 weeks | The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs. |
| Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 | 52 weeks | Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years |
| Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 | 156 weeks | Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Participants were from ARG, AUS, AUT, BEL, BRA, BGR, CAN, CHN, COL, CZE, EST, FIN, FRA, DEU, GRC, GTM, HUN, IND, ISR, JPN, LVA, LBN, LTU, MYS, MEX, NLD, PER, PHL, POL, ROU, RUS, SAU, SRB, SGP, SVK, ESP, CHE, TWN, TUR, GBR, USA
Pre-assignment details
Eligible patients included patients completing a prior QAW039 Phase 3 study (CQAW039A2307, QAW039A2314, CQAW039A2316, or CQAW039A2317) and patients who had not previously participated in a QAW039 study.
Participants by arm
| Arm | Count |
|---|---|
| QAW039 150mg QAW039 Dose 1 once daily | 1,092 |
| QAW039 450 mg QAW039 Dose 2 once daily | 1,084 |
| Placebo Placebo once daily | 361 |
| Total | 2,537 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 5 | 0 |
| Overall Study | Death | 3 | 0 | 1 |
| Overall Study | Lack of Efficacy | 23 | 14 | 7 |
| Overall Study | Lost to Follow-up | 2 | 4 | 0 |
| Overall Study | Non-Compliance With Study Treatment | 0 | 2 | 0 |
| Overall Study | Physician Decision | 4 | 5 | 1 |
| Overall Study | Pregnancy | 1 | 0 | 1 |
| Overall Study | Study Terminated By Sponsor | 928 | 938 | 296 |
| Overall Study | Subject/Guardian Decision | 50 | 45 | 22 |
| Overall Study | Technical Problems | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | QAW039 150mg | QAW039 450 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 50.1 Years STANDARD_DEVIATION 14.95 | 50.1 Years STANDARD_DEVIATION 15.55 | 49.9 Years STANDARD_DEVIATION 14.99 | 50.1 Years STANDARD_DEVIATION 15.21 |
| Race/Ethnicity, Customized Asian | 219 Participants | 215 Participants | 73 Participants | 507 Participants |
| Race/Ethnicity, Customized Black | 30 Participants | 14 Participants | 11 Participants | 55 Participants |
| Race/Ethnicity, Customized Caucasian | 757 Participants | 756 Participants | 243 Participants | 1756 Participants |
| Race/Ethnicity, Customized Native American | 27 Participants | 40 Participants | 12 Participants | 79 Participants |
| Race/Ethnicity, Customized Other | 59 Participants | 49 Participants | 20 Participants | 128 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 659 Participants | 666 Participants | 229 Participants | 1554 Participants |
| Sex: Female, Male Male | 433 Participants | 418 Participants | 132 Participants | 983 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 1,092 | 1 / 1,084 | 1 / 361 |
| other Total, other adverse events | 525 / 1,092 | 499 / 1,084 | 190 / 361 |
| serious Total, serious adverse events | 87 / 1,092 | 64 / 1,084 | 33 / 361 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 709 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 681 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 243 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.76, 1.02]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.73, 0.99]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.86, 1.08]Regression, Cox
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 675 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 654 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 237 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.74, 1]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.72, 0.97]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.87, 1.09]Regression, Cox
Primary
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 30 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 37 Participants |
| Placebo | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 9 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.56, 2.56]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.67, 2.95]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.7, 1.96]Regression, Cox
Primary
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 26 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 33 Participants |
| Placebo | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 9 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.47, 2.23]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.59, 2.64]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.7, 2.1]Regression, Cox
Primary
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 86 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 63 Participants |
| Placebo | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 33 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.54, 1.22]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.41, 0.97]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.55, 1.11]Regression, Cox
Primary
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QAW039 150mg | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 73 Participants |
| QAW039 450 mg | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 53 Participants |
| Placebo | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 29 Participants |
Comparison: Hazard Ratio = QAW039 150mg / Placebo95% CI: [0.51, 1.22]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / Placebo95% CI: [0.39, 0.97]Regression, Cox
Comparison: Hazard Ratio = QAW039 450mg / QAW039 150mg95% CI: [0.54, 1.14]Regression, Cox
Secondary
Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model
The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Logistic regression model were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Product issues | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Hepatobiliary disorders | 10 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Congenital, familial and genetic disorders | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Pregnancy, puerperium and perinatal conditions | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Immune system disorders | 11 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Blood and lymphatic system disorders | 23 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Nervous system disorders | 83 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Infections and infestations | 436 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Investigations | 90 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 17 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Injury, poisoning and procedural complications | 80 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Ear and labyrinth disorders | 18 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 102 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Number of patients with at least one AE | 710 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Metabolism and nutrition disorders | 61 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 336 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Endocrine disorders | 5 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Social circumstances | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Reproductive system and breast disorders | 17 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Eye disorders | 16 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Cardiac disorders | 16 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Renal and urinary disorders | 36 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Gastrointestinal disorders | 101 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Vascular disorders | 45 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Psychiatric disorders | 23 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | General disorders & administration site conditions | 43 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 45 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 341 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Number of patients with at least one AE | 682 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Blood and lymphatic system disorders | 12 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Cardiac disorders | 34 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Congenital, familial and genetic disorders | 3 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Ear and labyrinth disorders | 13 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Endocrine disorders | 7 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Eye disorders | 14 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Gastrointestinal disorders | 96 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | General disorders & administration site conditions | 34 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Hepatobiliary disorders | 21 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Immune system disorders | 11 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Infections and infestations | 415 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Injury, poisoning and procedural complications | 63 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Investigations | 102 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Metabolism and nutrition disorders | 60 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 92 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 11 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Nervous system disorders | 77 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Product issues | 0 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Psychiatric disorders | 18 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Renal and urinary disorders | 45 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Reproductive system and breast disorders | 10 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 45 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Social circumstances | 1 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Vascular disorders | 40 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Hepatobiliary disorders | 8 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Number of patients with at least one AE | 243 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Pregnancy, puerperium and perinatal conditions | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | General disorders & administration site conditions | 8 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 15 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Product issues | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Gastrointestinal disorders | 38 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Blood and lymphatic system disorders | 5 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Psychiatric disorders | 9 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Eye disorders | 9 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Vascular disorders | 13 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Renal and urinary disorders | 10 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Endocrine disorders | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Social circumstances | 3 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Reproductive system and breast disorders | 4 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Investigations | 24 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Ear and labyrinth disorders | 9 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Metabolism and nutrition disorders | 23 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Injury, poisoning and procedural complications | 28 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Congenital, familial and genetic disorders | 1 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 31 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Infections and infestations | 151 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 144 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 3 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Immune system disorders | 6 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Cardiac disorders | 7 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | Nervous system disorders | 32 Participants |
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo95% CI: [0.667, 1.125]Regression, Logistic
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo95% CI: [0.643, 1.082]Regression, Logistic
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg95% CI: [0.794, 1.167]Regression, Logistic
Secondary
Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model
The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Logistic regression model were included
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Eye disorders | 13 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Blood and lymphatic system disorders | 21 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Cardiac disorders | 11 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Congenital, familial and genetic disorders | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Ear and labyrinth disorders | 16 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Endocrine disorders | 2 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Number of patients with at least one AE | 675 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Gastrointestinal disorders | 88 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | General disorders & administration site conditions | 38 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Hepatobiliary disorders | 9 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Immune system disorders | 11 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Infections and infestations | 400 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Injury, poisoning and procedural complications | 67 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Investigations | 79 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Metabolism and nutrition disorders | 53 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 91 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 13 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Nervous system disorders | 67 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Product issues | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Psychiatric disorders | 18 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Renal and urinary disorders | 33 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Reproductive system and breast disorders | 14 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 308 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 38 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Social circumstances | 1 Participants |
| QAW039 150mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Vascular disorders | 39 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | General disorders & administration site conditions | 33 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Renal and urinary disorders | 41 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Hepatobiliary disorders | 17 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Immune system disorders | 10 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Social circumstances | 1 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Infections and infestations | 374 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Reproductive system and breast disorders | 9 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Injury, poisoning and procedural complications | 52 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Investigations | 85 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Metabolism and nutrition disorders | 50 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 304 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 84 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 9 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Nervous system disorders | 73 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Number of patients with at least one AE | 654 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Blood and lymphatic system disorders | 10 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 39 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Cardiac disorders | 26 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Product issues | 0 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Congenital, familial and genetic disorders | 3 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Ear and labyrinth disorders | 9 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Endocrine disorders | 6 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Psychiatric disorders | 15 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Eye disorders | 11 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Gastrointestinal disorders | 86 Participants |
| QAW039 450 mg | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Vascular disorders | 33 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Eye disorders | 9 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Ear and labyrinth disorders | 8 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Number of patients with at least one AE | 237 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Hepatobiliary disorders | 7 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Renal and urinary disorders | 8 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Nervous system disorders | 29 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Immune system disorders | 6 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Skin and subcutaneous tissue disorders | 13 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Blood and lymphatic system disorders | 5 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Infections and infestations | 145 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Psychiatric disorders | 9 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Endocrine disorders | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Injury, poisoning and procedural complications | 23 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Reproductive system and breast disorders | 4 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Cardiac disorders | 7 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Investigations | 20 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Social circumstances | 3 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | General disorders & administration site conditions | 7 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Metabolism and nutrition disorders | 21 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Gastrointestinal disorders | 32 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Congenital, familial and genetic disorders | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Musculoskeletal and connective tissue disorders | 24 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Respiratory, thoracic and mediastinal disorders | 135 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Product issues | 0 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Neoplasms benign, malignant and unspecified | 3 Participants |
| Placebo | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | Vascular disorders | 9 Participants |
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo95% CI: [0.626, 1.047]Regression, Logistic
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo95% CI: [0.622, 1.038]Regression, Logistic
Comparison: Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg95% CI: [0.821, 1.2]Regression, Logistic
Secondary
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156
The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QAW039 150mg | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 0 Number of deaths |
| QAW039 450 mg | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 0 Number of deaths |
| Placebo | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 0 Number of deaths |
Secondary
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52
The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QAW039 150mg | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 0 Number of deaths |
| QAW039 450 mg | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 0 Number of deaths |
| Placebo | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 0 Number of deaths |
Secondary
Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156
Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
Time frame: 156 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QAW039 150mg | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 | 0.04 Hospitalizations per person year |
| QAW039 450 mg | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 | 0.02 Hospitalizations per person year |
| Placebo | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156 | 0.05 Hospitalizations per person year |
Secondary
Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52
Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE). Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
Time frame: 52 weeks
Population: Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QAW039 150mg | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 | 0.04 Hospitalizations per person year |
| QAW039 450 mg | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 | 0.02 Hospitalizations per person year |
| Placebo | Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52 | 0.06 Hospitalizations per person year |