Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001560-11 | EudraCT Number |
Not provided
Not provided
Not provided
Company Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 150mg | Experimental | QAW039 Dose 1 once daily |
|
| QAW039 450 mg | Experimental | QAW039 Dose 2 once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 150 mg | Drug | One tablet of QAW039 150 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| 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 | 156 weeks |
| 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. | 52 weeks |
| 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. | 156 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Patients completing a prior Phase 3 study of QAW039:
Patients who have not previously participated in a study of QAW039:
Exclusion Criteria:
Patients completing a prior phase 3 study of QAW039:
Patients who have not previously participated in a study of QAW039:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34895218 | Derived | Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8. |
Not provided
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
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 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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | QAW039 150mg | QAW039 Dose 1 once daily |
| FG001 | QAW039 450 mg | QAW039 Dose 2 once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2020 | Sep 14, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| QAW039 450 mg |
| Drug |
One tablet of QAW039 450 mg once daily |
|
| Placebo | Drug | One tablet of Placebo once daily |
|
| 52 weeks |
| 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 | 156 weeks |
| 52 weeks |
| 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) | 156 weeks |
| 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. | 52 weeks |
| 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. | 156 weeks |
| 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 | 52 weeks |
| 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 | 156 weeks |
| Encinitas |
| California |
| 92024 |
| United States |
| Novartis Investigative Site | Newport Beach | California | 92663 | United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | San Diego | California | 92117 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Walnut Creek | California | 94598 | United States |
| Novartis Investigative Site | Westminster | California | 92683 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Denver | Colorado | 80230 | United States |
| Novartis Investigative Site | Lafayette | Colorado | 80026 | United States |
| Novartis Investigative Site | Miami | Florida | 33176 | United States |
| Novartis Investigative Site | Tamarac | Florida | 33321 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | Overland Park | Kansas | 66210 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40215 | United States |
| Novartis Investigative Site | Zachary | Louisiana | 70791 | United States |
| Novartis Investigative Site | Bangor | Maine | 04401 | United States |
| Novartis Investigative Site | Columbia | Maryland | 21044 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | United States |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | United States |
| Novartis Investigative Site | Missoula | Montana | 59804 | United States |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | United States |
| Novartis Investigative Site | La Vista | Nebraska | 68128 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | United States |
| Novartis Investigative Site | The Bronx | New York | 10459 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Gastonia | North Carolina | 28054 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43215 | United States |
| Novartis Investigative Site | Edmond | Oklahoma | 73034 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | Altoona | Pennsylvania | 16602 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15221 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Novartis Investigative Site | East Providence | Rhode Island | 02941 | United States |
| Novartis Investigative Site | Boerne | Texas | 78006 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76244 | United States |
| Novartis Investigative Site | McKinney | Texas | 75069 | United States |
| Novartis Investigative Site | Plano | Texas | 75093 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78205 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23225 | United States |
| Novartis Investigative Site | Bellingham | Washington | 98225 | United States |
| Novartis Investigative Site | Spokane | Washington | 99204 | United States |
| Novartis Investigative Site | Berazategui | Buenos Aires | 1888 | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1122AAK | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1425BEN | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1426ABP | Argentina |
| Novartis Investigative Site | Lanus | Buenos Aires | B8000XAV | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Ranelagh, Partido de Berazate | Buenos Aires | 1884 | Argentina |
| Novartis Investigative Site | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Novartis Investigative Site | Santa Fe | Rosario | S2000DBS | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000AII | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000BRH | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000JKR | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| Novartis Investigative Site | Buenos Aires | C1012AAR | Argentina |
| Novartis Investigative Site | Buenos Aires | C1125ABE | Argentina |
| Novartis Investigative Site | Buenos Aires | C1425FVH | Argentina |
| Novartis Investigative Site | Córdoba | X5003DCE | Argentina |
| Novartis Investigative Site | Mendoza | 5500 | Argentina |
| Novartis Investigative Site | Mendoza | M5500CBA | Argentina |
| Novartis Investigative Site | Salta | 4000 | Argentina |
| Novartis Investigative Site | Santa Fe | S3000FIL | Argentina |
| Novartis Investigative Site | Clayton | Victoria | 3168 | Australia |
| Novartis Investigative Site | Footscray | Victoria | 3011 | Australia |
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Feldkirch | 6800 | Austria |
| Novartis Investigative Site | Vienna | A 1090 | Austria |
| Novartis Investigative Site | Vienna | A-1130 | Austria |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Brussels | 1020 | Belgium |
| Novartis Investigative Site | Erpent | 5100 | Belgium |
| Novartis Investigative Site | Éghezée | 5310 | Belgium |
| Novartis Investigative Site | Herentals | 2200 | Belgium |
| Novartis Investigative Site | Kortrijk | 8500 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Goiânia | Goiás | 74110-030 | Brazil |
| Novartis Investigative Site | Porto Alegre | Porto Alegre RS | 90610 000 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Novartis Investigative Site | Blumenau | Santa Catarina | 89030101 | Brazil |
| Novartis Investigative Site | São Bernardo do Campo | São Paulo | 09715 090 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403 000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05437 010 | Brazil |
| Novartis Investigative Site | Sorocaba | São Paulo | Brazil |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Rousse | 7002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1000 | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M6H 3M2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M9V 4B4 | Canada |
| Novartis Investigative Site | Windsor | Ontario | N8X 5A6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3G 1L5 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1E2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H4J 1C5 | Canada |
| Novartis Investigative Site | Québec | G1V 4W2 | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Guangzhou | Guangdong | 510120 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 050000 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210006 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210009 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110000 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110003 | China |
| Novartis Investigative Site | Xian | Shanxi | 710061 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Beijing | 100050 | China |
| Novartis Investigative Site | Chongqing | 400037 | China |
| Novartis Investigative Site | Shanghai | 200433 | China |
| Novartis Investigative Site | Ibague | Tolima Department | 730006 | Colombia |
| Novartis Investigative Site | Bogotá | 110221 | Colombia |
| Novartis Investigative Site | Bucaramanga | Colombia |
| Novartis Investigative Site | Jindřichův Hradec | Czech Republic | 377 01 | Czechia |
| Novartis Investigative Site | Teplice | Czech Republic | 415 01 | Czechia |
| Novartis Investigative Site | Teplice | CZE | 415 01 | Czechia |
| Novartis Investigative Site | Brno | 615 00 | Czechia |
| Novartis Investigative Site | Karlovy Vary | 360 17 | Czechia |
| Novartis Investigative Site | Mladá Boleslav | 293 50 | Czechia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Helsinki | 00029 | Finland |
| Novartis Investigative Site | Montpellier | Herault | 34059 | France |
| Novartis Investigative Site | Dijon | 21000 | France |
| Novartis Investigative Site | Le Kremlin-Bicêtre | 94275 | France |
| Novartis Investigative Site | Lyon | 69317 | France |
| Novartis Investigative Site | Marseille | 13015 | France |
| Novartis Investigative Site | Nantes | 44093 | France |
| Novartis Investigative Site | Paris | 75877 | France |
| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Cottbus | Saxony | 03050 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Berlin | 10717 | Germany |
| Novartis Investigative Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Berlin | 12159 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Landsberg | 86899 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |
| Novartis Investigative Site | Athens | GR | 115 25 | Greece |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 570 10 | Greece |
| Novartis Investigative Site | Athens | 115 21 | Greece |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 175 62 | Greece |
| Novartis Investigative Site | Gautemala City | Gautemala | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | GTM | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | GTM | 01011 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01010 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01011 | Guatemala |
| Novartis Investigative Site | Budaörs | HUN | 2040 | Hungary |
| Novartis Investigative Site | Győr | HUN | 9024 | Hungary |
| Novartis Investigative Site | Hajdúnánás | HUN | 4080 | Hungary |
| Novartis Investigative Site | Püspökladány | HUN | 4150 | Hungary |
| Novartis Investigative Site | Százhalombatta | HUN | 2440 | Hungary |
| Novartis Investigative Site | Budapest | 1106 | Hungary |
| Novartis Investigative Site | Gödöllő | 2100 | Hungary |
| Novartis Investigative Site | Komárom | 2900 | Hungary |
| Novartis Investigative Site | Makó | 6900 | Hungary |
| Novartis Investigative Site | Pécs | 7635 | Hungary |
| Novartis Investigative Site | Siófok | 8600 | Hungary |
| Novartis Investigative Site | Szeged | 6722 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 060 | India |
| Novartis Investigative Site | Vadodara | Gujarat | 390022 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440015 | India |
| Novartis Investigative Site | Pune | Maharashtra | 411014 | India |
| Novartis Investigative Site | Bikaner | Rajasthan | 334 001 | India |
| Novartis Investigative Site | Jaipur | Rajasthan | 302039 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 045 | India |
| Novartis Investigative Site | Dehradun | Uttarakhand | 248001 | India |
| Novartis Investigative Site | Ashkelon | 78278 | Israel |
| Novartis Investigative Site | Haifa | 310 9601 | Israel |
| Novartis Investigative Site | Haifa | 3436212 | Israel |
| Novartis Investigative Site | Jerusalem | 91031 | Israel |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Rehovot | 76100 | Israel |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466 8560 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-0024 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-8524 | Japan |
| Novartis Investigative Site | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-1394 | Japan |
| Novartis Investigative Site | Iizuka | Fukuoka | 820-8505 | Japan |
| Novartis Investigative Site | Kasuga | Fukuoka | 816-0813 | Japan |
| Novartis Investigative Site | Koga | Fukuoka | 811 3195 | Japan |
| Novartis Investigative Site | Yanagawa | Fukuoka | 832-0059 | Japan |
| Novartis Investigative Site | Mizunami | Gifu | 509 6134 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 734-8530 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 062-0931 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 064-0804 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 672-8064 | Japan |
| Novartis Investigative Site | Naka-gun | Ibaraki | 319-1113 | Japan |
| Novartis Investigative Site | Sakaidechō | Kagawa-ken | 762-8550 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 761-8073 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 890 8520 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 228-8522 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 229-1103 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 223-0059 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232 0024 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 234-0054 | Japan |
| Novartis Investigative Site | Kōshi | Kumamoto | 861-1196 | Japan |
| Novartis Investigative Site | Matsusaka | Mie-ken | 515-8544 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-0125 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-0871 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 984-8560 | Japan |
| Novartis Investigative Site | Kashihara | Nara | 634 8522 | Japan |
| Novartis Investigative Site | Habikino | Osaka | 583 8588 | Japan |
| Novartis Investigative Site | Kishiwada | Osaka | 596-8501 | Japan |
| Novartis Investigative Site | Tokyo | Shibuya Ku | 150 0013 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104-0031 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0003 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0028 | Japan |
| Novartis Investigative Site | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-8585 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 145 0063 | Japan |
| Novartis Investigative Site | Setagaya-Ku | Tokyo | 157-0072 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157006 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8655 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Novartis Investigative Site | Toshima Ku | Tokyo | 170 0003 | Japan |
| Novartis Investigative Site | Daugavpils | LV-5401 | Latvia |
| Novartis Investigative Site | Riga | LV 1002 | Latvia |
| Novartis Investigative Site | El Chouf | LBN | 1503201002 | Lebanon |
| Novartis Investigative Site | Beirut | 166378 | Lebanon |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Kaunas | LTU | LT 50161 | Lithuania |
| Novartis Investigative Site | Vilnius | LTU | LT-10207 | Lithuania |
| Novartis Investigative Site | Kaunas | LT | LT-45130 | Lithuania |
| Novartis Investigative Site | Kaunas | LT | LT-50128 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92231 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-04129 | Lithuania |
| Novartis Investigative Site | Kota Bharu | Kelantan | 15586 | Malaysia |
| Novartis Investigative Site | Kuantan | Pahang | 25100 | Malaysia |
| Novartis Investigative Site | Taiping | Perak | 34000 | Malaysia |
| Novartis Investigative Site | Guadalajara | Jalisco | 44130 | Mexico |
| Novartis Investigative Site | Guadalajara Jalisco | Jalisco | 44220 | Mexico |
| Novartis Investigative Site | Río de Janeiro | 06700 | Mexico |
| Novartis Investigative Site | Arnhem | 6815 AD | Netherlands |
| Novartis Investigative Site | Leeuwarden | 8934 AD | Netherlands |
| Novartis Investigative Site | Lima Cercado | Lima region | 01 | Peru |
| Novartis Investigative Site | San Isidro | Lima region | 27 | Peru |
| Novartis Investigative Site | San Martín de Porres | Lima region | 31 | Peru |
| Novartis Investigative Site | Cusco | 84 | Peru |
| Novartis Investigative Site | Lima | 1 | Peru |
| Novartis Investigative Site | Piura | 2000 | Peru |
| Novartis Investigative Site | Lipa City | Batangas | 4217 | Philippines |
| Novartis Investigative Site | Quezon City | Manila | 1100 | Philippines |
| Novartis Investigative Site | Bulacan | 3020 | Philippines |
| Novartis Investigative Site | Iloilo City | 5000 | Philippines |
| Novartis Investigative Site | Manila | 1000 | Philippines |
| Novartis Investigative Site | Quezon City | 1100 | Philippines |
| Novartis Investigative Site | Bialystok | 15-010 | Poland |
| Novartis Investigative Site | Kielce | 25-371 | Poland |
| Novartis Investigative Site | Poznan | 60-214 | Poland |
| Novartis Investigative Site | Poznan | 60-693 | Poland |
| Novartis Investigative Site | Poznan | 60-823 | Poland |
| Novartis Investigative Site | Strzelce Opolskie | 47 100 | Poland |
| Novartis Investigative Site | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | Bucharest | District 3 | 030303 | Romania |
| Novartis Investigative Site | Constanța | ROM | 900412 | Romania |
| Novartis Investigative Site | Timișoara | Timiș County | 300310 | Romania |
| Novartis Investigative Site | Bragadiru | 077025 | Romania |
| Novartis Investigative Site | Brasov | 500051 | Romania |
| Novartis Investigative Site | Brasov | 500086 | Romania |
| Novartis Investigative Site | Brasov | 500283 | Romania |
| Novartis Investigative Site | Brasov | 500366 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400139 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400371 | Romania |
| Novartis Investigative Site | Deva | 330162 | Romania |
| Novartis Investigative Site | Barnaul | 656024 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454021 | Russia |
| Novartis Investigative Site | Izhevsk | 426061 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Moscow | 125315 | Russia |
| Novartis Investigative Site | Nizhny Novgorod | 603126 | Russia |
| Novartis Investigative Site | Penza | 440067 | Russia |
| Novartis Investigative Site | Perm | 614068 | Russia |
| Novartis Investigative Site | Ryazan | 390039 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191186 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194354 | Russia |
| Novartis Investigative Site | Sestroretsk | 197706 | Russia |
| Novartis Investigative Site | Smolensk | Russia |
| Novartis Investigative Site | Stavropol | 355000 | Russia |
| Novartis Investigative Site | Yaroslavl | 150054 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620109 | Russia |
| Novartis Investigative Site | Jeddah | 21423 | Saudi Arabia |
| Novartis Investigative Site | Belgrade | 11000 | Serbia |
| Novartis Investigative Site | Belgrade | 11070 | Serbia |
| Novartis Investigative Site | Kamenitz | 21204 | Serbia |
| Novartis Investigative Site | Kragujevac | 34000 | Serbia |
| Novartis Investigative Site | Niš | 18000 | Serbia |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Singapore | 529889 | Singapore |
| Novartis Investigative Site | Bardejov | Slovak Republic | 085 01 | Slovakia |
| Novartis Investigative Site | Bojnice | Slovak Republic | 972 01 | Slovakia |
| Novartis Investigative Site | Kežmarok | 060 01 | Slovakia |
| Novartis Investigative Site | Komárno | 945 01 | Slovakia |
| Novartis Investigative Site | Košice | 040 01 | Slovakia |
| Novartis Investigative Site | Levice | 934 01 | Slovakia |
| Novartis Investigative Site | Levice | 93401 | Slovakia |
| Novartis Investigative Site | Poprad | 058 01 | Slovakia |
| Novartis Investigative Site | Prešov | 080 01 | Slovakia |
| Novartis Investigative Site | Spišská Nová Ves | 052 01 | Slovakia |
| Novartis Investigative Site | Žilina | 01207 | Slovakia |
| Novartis Investigative Site | Marbella | Andalusia | 29603 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29009 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Novartis Investigative Site | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Novartis Investigative Site | Laredo | Cantabria | 39770 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Lugo | Galicia | 27003 | Spain |
| Novartis Investigative Site | Barcelona | Vic | 08500 | Spain |
| Novartis Investigative Site | Barcelona | 08006 | Spain |
| Novartis Investigative Site | Girona | 17005 | Spain |
| Novartis Investigative Site | Guadalajara | 19002 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Santiago de Compostela | 15706 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Liestal | 4410 | Switzerland |
| Novartis Investigative Site | Lugano | 6900 | Switzerland |
| Novartis Investigative Site | Taichung | 40705 | Taiwan |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Bursa | 16059 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33343 | Turkey (Türkiye) |
| Novartis Investigative Site | Yenisehir/Izmir | 35110 | Turkey (Türkiye) |
| Novartis Investigative Site | Cambridge | Cambrigdeshire | CB2 0QQ | United Kingdom |
| Novartis Investigative Site | Plymouth | Devon | PL6 8DH | United Kingdom |
| Novartis Investigative Site | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | East Yorkshire | HU16 5JQ | United Kingdom |
| Novartis Investigative Site | Leicester | LE3 9QP | United Kingdom |
| FG002 |
| Placebo |
Placebo once daily |
| Safety Set (SAF) | All patients who received at least one dose of study drug during this study. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
SAF: All patients who received at least one dose of study drug during this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QAW039 150mg | QAW039 Dose 1 once daily |
| BG001 | QAW039 450 mg | QAW039 Dose 2 once daily |
| BG002 | Placebo | Placebo once daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Count of Participants | Participants | 52 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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 | Posted | Count of Participants | Participants | 156 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | 156 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Count of Participants | Participants | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Count of Participants | Participants | 156 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | 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 | Posted | Count of Participants | Participants | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | 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. | Posted | Count of Participants | Participants | 156 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Number of deaths | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | Number of deaths | 156 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | Hospitalizations per person year | 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | Hospitalizations per person year | 156 weeks |
|
Adverse events were collected from first dose of study treatment until end of study treatment plus 7 days post treatment (30 days in the case of a serious AE), up to maximum duration of 156 weeks.
Any sign or symptom that occurs during the study treatment plus the 7 days post treatment (30 days in the case of a serious AE).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QAW039 150 mg | QAW039 150 mg | 3 | 1,092 | 87 | 1,092 | 525 | 1,092 |
| EG001 | QAW039 450 mg | QAW039 450 mg | 1 | 1,084 | 64 | 1,084 | 499 | 1,084 |
| EG002 | Placebo | Placebo | 1 | 361 | 33 | 361 | 190 | 361 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Fibrous dysplasia of bone | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skeletal dysplasia | Congenital, familial and genetic disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Peritoneal cyst | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperplasia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Dengue haemorrhagic fever | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Vaginal abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Exposure to allergen | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Electrocardiogram Q wave abnormal | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Myeloproliferative neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Brain stem haemorrhage | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Colloid brain cyst | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 17, 2018 | Sep 14, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604875 | fevipiprant |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Unknown |
|
| Other |
|
Hazard Ratio = QAW039 450mg / Placebo |
| Regression, Cox |
The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum |
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.72 |
| 0.97 |
A hazard ratio < 1 favors the treatment group in the numerator of the ratio. |
| Other |
| Hazard Ratio = QAW039 450mg / QAW039 150mg | Regression, Cox | The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum | Hazard Ratio (HR) | 0.97 | 2-Sided | 95 | 0.87 | 1.09 | A hazard ratio < 1 favors the treatment group in the numerator of the ratio. | Other |
|
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|