Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003985-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etrasimod 2 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 12 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 12 |
| Percentage of Participants Achieving Clinical Remission at Week 52 | Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Endoscopic Improvement at Week 12 | Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). | At Week 12 |
| Percentage of Participants Achieving Endoscopic Improvement at Week 52 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| Arizona Digestive Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42248437 | Derived | Danese S, Goetsch M, Peyrin-Biroulet L, Yarur AJ, Dubinsky M, Rubin DT, Feagan BG, D'Haens G, Baert F, Lazin K, Gu G, Yu J, Lawendy N, Zang C, Wang W, Menon S, Law EH, Modesto I, Wosik K, Sidhu S, Niezychowski W, Vermeire S. The Efficacy and Safety of Etrasimod in Mildly to Moderately Active Ulcerative Colitis: Results From the Phase II GLADIATOR Trial. Clin Gastroenterol Hepatol. 2026 Jun 4:S1542-3565(26)00405-2. doi: 10.1016/j.cgh.2026.05.024. Online ahead of print. | |
| 41655066 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study included a Screening Period (up to 28 days), a 12-Week Treatment Period (induction) followed by a 40-Week Treatment Period (maintenance; for which no re-randomization took place), and a 2-Week and 4-Week Follow-Up Period.
Participants with moderately to severely active ulcerative colitis (UC) were enrolled in this study. Eligible participants were randomized in a 2:1 ratio to receive either etrasimod 2 milligrams (mg) once daily or matching placebo once daily for up to 52 weeks.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etrasimod 2 mg | Etrasimod 2 mg was administered orally once daily for up to 52 weeks. |
| FG001 | Placebo | Placebo was administered orally once daily for up to 52 weeks. |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2020 | Nov 3, 2022 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment |
|
Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). |
| At Week 52 |
| Percentage of Participants Achieving Symptomatic Remission at Week 12 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | At Week 12 |
| Percentage of Participants Achieving Symptomatic Remission at Week 52 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | At Week 52 |
| Percentage of Participants With Mucosal Healing at Week 12 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | At Week 12 |
| Percentage of Participants With Mucosal Healing at Week 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | At Week 52 |
| Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 | Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 52 |
| Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 | Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Weeks 12 and 52 |
| Percentage of Participants Achieving Clinical Response at Week 12 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 12 |
| Percentage of Participants Achieving Clinical Response at Week 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 52 |
| Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Weeks 12 and 52 |
| Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | At Weeks 12 and 52 |
| Percentage of Participants Achieving Endoscopic Normalization at Week 12 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | At Week 12 |
| Percentage of Participants Achieving Endoscopic Normalization at Week 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | At Week 52 |
| Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | At Weeks 12 and 52 |
| Percentage of Participants Achieving Symptomatic Remission by Study Visit | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48 |
| Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52 |
| Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
| Percentage of Participants Achieving Symptomatic Response by Study Visit | Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
| Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline | Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 52 |
| Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 | Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | At Week 52 |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Om Research, LLC | Lancaster | California | 93534 | United States |
| Entertainment Medical Group, Inc. | Los Angeles | California | 90036 | United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| San Diego Gastroenterology Medical Associates | San Diego | California | 92103 | United States |
| ACRC Studies, LLC | San Diego | California | 92119 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80920 | United States |
| Gastro Florida | Clearwater | Florida | 33761 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | United States |
| Florida Center for Gastroenterology | Clearwater | Florida | 33777 | United States |
| Javier Sobrado, MD | Miami | Florida | 33156 | United States |
| Life Medical Center & Research, INC | Miami Lakes | Florida | 33014 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| Office of Dr Meckstroth | Naples | Florida | 34110 | United States |
| NSB Research | New Smyrna Beach | Florida | 32168 | United States |
| Sarkis Clinical Trials - Parent | Ocala | Florida | 34474 | United States |
| IMIC, Inc. | Palmetto Bay | Florida | 33157 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Theia Clinical Research, LLC | St. Petersburg | Florida | 33709 | United States |
| Advanced Research Institute, Inc. | St. Petersburg | Florida | 33710 | United States |
| Lenus Research & Medical Group | Sweetwater | Florida | 33172 | United States |
| USF Physicians Group | Tampa | Florida | 33606 | United States |
| GCP Clinical Research | Tampa | Florida | 33609 | United States |
| Guardian Angel Research Center | Tampa | Florida | 33614 | United States |
| ASCLEPES Research Centers, P.C. | Weeki Wachee | Florida | 34607 | United States |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | United States |
| Atlanta Gastroenterology Associates LLC | Atlanta | Georgia | 30342 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| Illinois Gastroenterology Group | Gurnee | Illinois | 60031 | United States |
| Gen1 Research | Moline | Illinois | 61265 | United States |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | United States |
| CroNOLA | Houma | Louisiana | 70360 | United States |
| Clinical Trials of SW Louisiana, LLC | Lake Charles | Louisiana | 70601 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Flint Clinical Research | Flint | Michigan | 48503 | United States |
| Robert Ferguson MD | West Bloomfield | Michigan | 48323 | United States |
| Gastrointestinal Associates | Flowood | Mississippi | 39232 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | United States |
| Duke University Medical Center GI Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Great Lakes Medical Research, LLC | Mentor | Ohio | 44060 | United States |
| Care Access Research | Poland | Ohio | 44514 | United States |
| Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | 73112 | United States |
| Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | 17110 | United States |
| GI for Kids | Knoxville | Tennessee | 37916 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Coastal Medical Group | Baytown | Texas | 77521 | United States |
| Texas Gastroenterology Associates, PA | Cypress | Texas | 77429 | United States |
| Texas Digestive Disease Consultants | Dallas | Texas | 76092 | United States |
| Digestive Health Associates of Texas | Garland | Texas | 75044 | United States |
| CliniCore Texas | Houston | Texas | 77029 | United States |
| Baylor Gastroenterology Assoc | Houston | Texas | 77030 | United States |
| Biopharma Informatic, Inc. Research Center | Houston | Texas | 77043 | United States |
| Rio Grande Gastroenterology | McAllen | Texas | 78503 | United States |
| Biopharma Informatic, Inc. Research Center | Pasadena | Texas | 77505 | United States |
| Texas Digestive Disease Consultants - San Marcos | San Marcos | Texas | 78130 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Victoria Gastroenterology | Victoria | Texas | 77904 | United States |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | United States |
| Washington Gastroenterology | Bellevue | Washington | 98004 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Marshall University Department of Clinical Research | Huntington | West Virginia | 25701 | United States |
| Medical College of Wisconsin Clinical Trials Office | Milwaukee | Wisconsin | 53226-0509 | United States |
| Clinica Adventista Belgrano | CABA | Buenos Aires | C1430EGF | Argentina |
| Mautalen Salud e Investigacion | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1128AAF | Argentina |
| Fundación Respirar- Centro Médico Dra. De Salvo | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| CICE Sanatorio 9 de Julio | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Bankstown-Lidcombe Hospital | Bankstown | New South Wales | 2200 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| Coastal Digestive Health Pty Ltd | Maroochydore | Queensland | 4558 | Australia |
| Coral Sea Clinical Research Institute | North Mackay | Queensland | 4740 | Australia |
| Austin Health Gastroenterology Department | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| KH der Barmherzigen Brüder Linz | Linz | 4020 | Austria |
| AKH - Medizinische Universität Wien | Vienna | 1090 | Austria |
| Wilhelminenspital der Stadt Wien | Vienna | 1160 | Austria |
| Grodno City Clinical Hospital #4 | Grodno | 230026 | Belarus |
| Institution "Gomel Regional Clinical Hospital" | Homyel | 246029 | Belarus |
| Health Care Institution "10th City Clinical Hospital" | Minsk | 220096 | Belarus |
| Vitebsk Regional Clinical Hospital | Vitebsk | 210037 | Belarus |
| Vitebsk Regional Clinical Specialized Center | Vitebsk | 210604 | Belarus |
| AZ Sint-Lucas & Volkskliniek | Ghent | 9000 | Belgium |
| UZ Gent Gastroenterology | Ghent | 9000 | Belgium |
| ZNA Jan Palfijn | Merksem | 2170 | Belgium |
| AZ Delta | Roeselare | Belgium |
| Medical center Medconsult Pleven OOD | Pleven | 5800 | Bulgaria |
| UMHAT Kanev AD, Ruse | Rousse | 7002 | Bulgaria |
| Diagnostic-Consultative Center I - Sliven, EOOD | Sliven | 8800 | Bulgaria |
| ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center | Sofia | 1407 | Bulgaria |
| DCC "Alexandrovska", EOOD | Sofia | 1431 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology | Sofia | 1431 | Bulgaria |
| UMHAT Tsaritsa Yoanna-ISUL EAD | Sofia | 1527 | Bulgaria |
| UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney | Sofia | 1606 | Bulgaria |
| Diagnostic Consultation Center CONVEX EOOD | Sofia | 1680 | Bulgaria |
| Acibadem City Clinic University Hospital EOOD | Sofia | 1784 | Bulgaria |
| Medical Center Nov Rehabilitatsionen Tsentar EOOD | Stara Zagora | 6000 | Bulgaria |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Enroll SpA | Santiago | 7500588 | Chile |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Hospital Sotero del Rio | Santiago | 8150000 | Chile |
| Centro de Investigación del Maule SPA | Talca | 3465586 | Chile |
| Clinical Research Chile SpA | Valdivia | 5090000 | Chile |
| General Hospital "Dr.Tomislav Bardek" Koprivnica | Koprivnica | 48000 | Croatia |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| General Hospital Zadar | Zadar | 23000 | Croatia |
| Clinical Hospital Dubrava | Zagreb | 10000 | Croatia |
| Clinical Hospital Sveti Duh | Zagreb | 10000 | Croatia |
| Polyclinic Bonifarm | Zagreb | 10000 | Croatia |
| University hospital centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u svate Anny v Brne | Brno | 656 91 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o., | Hradec Králové | 500 12 | Czechia |
| GASTRO JeKa, s.r.o. | Klatovy | 339 01 | Czechia |
| PreventaMed s.r.o. | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| ISCARE I.V.F. a.s. | Prague | 170 04 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 81 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Aalborg University Hospital, department of medical gastroenterology | Aalborg | North Denmark | 9000 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Innomedica OÜ | Tallinn | 10117 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| CHU Nice - Hôpital de l'Archet 2 | Nice | Alpes Maritimes | 06202 | France |
| CHU Montpellier - HOPITAL SAINT-ELOI | Montpellier | Herault | 34295 | France |
| CHU Nantes Hôtel-Dieu | Nantes | Loire Atlantique | 44000 | France |
| CHU Grenoble Alpes - Hôpital Michallon | Grenoble | 38043 | France |
| CHRU-Nancy Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine | Tbilisi | 0112 | Georgia |
| LTD Israeli-Georgian Medical Research clinic Helsicore | Tbilisi | 0112 | Georgia |
| LLC Vivamedi | Tbilisi | 0131 | Georgia |
| LTD Institute of Clinical Cardiology | Tbilisi | 0159 | Georgia |
| JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | 0160 | Georgia |
| LTD Aversi Clinic | Tbilisi | 0160 | Georgia |
| LTD Central University Clinic After Academic N. Kipshidze | Tbilisi | 0160 | Georgia |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Tbilisi | 0172 | Georgia |
| Praxis Dr. Joergensen | Remscheid | North Rhine-Westphalia | 42859 | Germany |
| Schwerpunktpraxis Bonn | Bonn | Rhineland-Palatinate | 53123 | Germany |
| Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Krankenhaus Waldfriede | Berlin | 14163 | Germany |
| Florence-Nightingale-Krankenhaus | Düsseldorf | 40489 | Germany |
| Johanna Etienne Krankenhaus | Neuss | 41462 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | 8230 | Hungary |
| Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia | Békéscsaba | 5600 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | 1136 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| SZTE AOK I.st dept. of Internal Medicine. | Szeged | 6720 | Hungary |
| Clinfan Ltd. Outpatient Clinic | Szekszárd | 7100 | Hungary |
| 1th Dept of Gastroenterology, Szent Gyorgy Hospital | Székesfehérvár | 8000 | Hungary |
| Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Asian Institute of Gastroenterology | Hyderabad | Andhra Pradesh | 500032 | India |
| Nirmal Hospitals Pvt Ltd | Surat | Gujarat | 395002 | India |
| Surat Institute of Digestive Sciences | Surat | Gujarat | 395002 | India |
| Fortis Memorial Research Institute | Gurgaon | Haryana | 122002 | India |
| Aster Medcity,Aster DM healthcare Ltd | Kochi | Kerala | 682027 | India |
| Midas Multispeciality Hospital-Nagpur | Nagpur | Maharashtra | 440010 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Shweta Paliwal/Vipin Kumar Jain | Jaipur | Rajasthan | 302001 | India |
| Postgraduate department of Medicine, GSVM Medical college | Kanpur | Uttar Pradesh | 208002 | India |
| HaEmek Medical Center | Afula | 1834111 | Israel |
| Bnei Zion Medical Center | Haifa | 3339419 | Israel |
| Wolfson Medical Center | Holon | 5810001 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Galilee Medical Center | Nahariya | 2210001 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262000 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Azienda Ospedaliera Saverio De Bellis | Castellana Grotte | Bari | 70013 | Italy |
| Ospedale di Circolo | Rho | Milano | 20017 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese | Milano | 20097 | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | Verona | 37024 | Italy |
| Spedali Civili di Brescia, U.O. Gastroenterologia | Brescia | 25123 | Italy |
| Azienda Ospedaliera Ospedale Cannizzaro | Catania | 95126 | Italy |
| Magna Graecia University | Catanzaro | 88100 | Italy |
| A.O.U. Policlinico di Modena | Modena | 41124 | Italy |
| Ospedale Sandro Pertini | Roma | 00157 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD | Roma | 00168 | Italy |
| Ospedale San Bortolo di Vicenza | Vicenza | 36100 | Italy |
| P. Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Saint George University Hospital Medical Center | Beirut | 1100 2807 | Lebanon |
| Kaunas Clinical Hospital | Kaunas | LT-47144 | Lithuania |
| Klaipeda University Hospital, Department of Gastroenterology | Klaipėda | LT-92288 | Lithuania |
| Republican Panevezys Hospital, Department of Gastroenterology | Panevezys | LT-35144 | Lithuania |
| UAB "Inlita", Santaros Clinical Trials Centre | Vilnius | LT-08406 | Lithuania |
| Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology | Vilnius | LT-08661 | Lithuania |
| Centro de Investigacion Medico Biologica y Terapia Avanzada s.c. | Guadalajara | Jalisco | 44130 | Mexico |
| InspirePharma S. de R. L. de C.V. | Monterrey | Nuevo León | 64660 | Mexico |
| Scientia Investigación Clínica S.C. | Chihuahua City | 31203 | Mexico |
| Hospital Angeles Chihuahua | Chihuahua City | 31238 | Mexico |
| Faicic S. de R.L. de Cv | Veracruz | 91900 | Mexico |
| Clinical Hospital of the Ministry of Health, Labor and Social Protection | Chisinau | MD-2005 | Moldova |
| Rtl Sm Srl | Chisinau | MD-2025 | Moldova |
| Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology | Chisinau | MD-2025 | Moldova |
| RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie | Chisinau | MD-2068 | Moldova |
| Zuyderland Medisch Centrum - Sittard-Geleen | Geleen | 6162 BG | Netherlands |
| ETZ Elisabeth | Tilburg | 5022 GC | Netherlands |
| Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz | Będzin | 42-500 | Poland |
| Gastromed Kralisz, Romatowski, Stachurska sp.j | Bialystok | 15-322 | Poland |
| Centrum Medyczne Pratia Czestochowa | Częstochowa | 42-200 | Poland |
| Karkonoskie Centrum Badan Klinicznych Lexmedica | Jelenia Góra | 58-500 | Poland |
| Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna | Krakow | 31-506 | Poland |
| AmiCare Sp. z O.O. Sp.K. | Lodz | 90-644 | Poland |
| IP Clinic | Lodz | 90-752 | Poland |
| Med-Gastr Przychodnia Specjalistyczna | Lodz | 91-034 | Poland |
| Allmedica Badania Kliniczne Sp. z o.o. Sp.k. | Nowy Targ | 34-400 | Poland |
| Medicenter Nowy Targ | Nowy Targ | 34-400 | Poland |
| Medicome Sp. Zo.O. | Oświęcim | 32-600 | Poland |
| Centrum Medyczne Grunwald | Poznan | 60-369 | Poland |
| SOLUMED Centrum Medyczne | Poznan | 60-529 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| ENDOSKOPIA Sp.zo.o | Sopot | 81-756 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-635 | Poland |
| Centralny Szpital Kliniczny MSW w Warszawie | Warsaw | 02-507 | Poland |
| EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji | Wroclaw | 144-148 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Jerzy Rozciecha- Lexmedica | Wroclaw | 53-114 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar de São João, EPE | Porto | 4200-319 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Vila Nova de Gaia | 4434-502 | Portugal |
| S.C Policlinica CCBR S.R.L | Bucharest | 030463 | Romania |
| S.C MedLife SA | Bucharest | 10719 | Romania |
| Dr. Carol Davila Central University Emergency Military Hospital | Bucharest | 10825 | Romania |
| Delta Health Care srl | Bucharest | 14142 | Romania |
| S.C Euroclinic Hospital S.A | Bucharest | 14461 | Romania |
| Spitalul Clinic Colentina | Bucharest | 20125 | Romania |
| Institutul Clinic Fundeni | Bucharest | 22328 | Romania |
| Centrul Medical Unirea srl | Bucharest | 540136 | Romania |
| Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | 400006 | Romania |
| Spitalul Clinic Judetean de Urgenta | Craiova | 200640 | Romania |
| Cabinet Medical Dr. Fratila S.R.L | Oradea | 410167 | Romania |
| S.C Pelican Impex S.R.L | Oradea | 410469 | Romania |
| LLC "Multidisciplinary Medical Clinic "Anthurium" | Barnaul | 656043 | Russia |
| LLC "Alyans Biomedical- Ural Group" | Irkutsk | 664049 | Russia |
| Kazan State Medical University | Kazan' | 420012 | Russia |
| SAIH "Kemerovo Regional Clinical Hospital | Kemerovo | 650066 | Russia |
| SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" | Nizhny Novgorod | 603126 | Russia |
| LLC Medicine Center SibNovoMed | Novosibirsk | 630005 | Russia |
| CDC Ultramed | Omsk | 644024 | Russia |
| State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko" | Penza | 440026 | Russia |
| LLC "Medinet" | Saint Petersburg | 194356 | Russia |
| Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University" | Saint Petersburg | 195067 | Russia |
| LLC SM-Clinic | Saint Petersburg | 195279 | Russia |
| LLC "Gastroenterological centre Expert" | Saint Petersburg | 197110 | Russia |
| Irkutsk State Medical Academy of Continuing Education | Samara | 443011 | Russia |
| Private Educational Institution of Higher Education "Medical University REAVIZ" | Samara | 443011 | Russia |
| LLC Medical Company "Hepatologist" | Samara | 443093 | Russia |
| SPb SBIH "City Hospital # 40 of Kurortnyi region" | Sestroretsk | 197706 | Russia |
| LLC Uromed | Smolensk | 214031 | Russia |
| Stavropol Regional Clinical Diagnostic Centre | Stavropol | 355017 | Russia |
| LLC "Polyclinic of ultrasonography 4D" | Stavropol | 357000 | Russia |
| Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Health Center Zvezdara | Belgrade | 11000 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| General Hospital Sremska Mitrovica | Sremska Mitrovica | 22000 | Serbia |
| ENDOMED, s.r.o. | Vranov nad Topľou | Presov | 093 01 | Slovakia |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Alian S.R.O | Bardejov | 085 01 | Slovakia |
| KM Management spol. s r.o. | Nitra | 949 01 | Slovakia |
| Fakultna nemocnica Nitra | Nitra | 950 01 | Slovakia |
| GASTROENTEROLOG, s.r.o. | Nové Zámky | 940 01 | Slovakia |
| Gastro I, s.r.o. | Prešov | 080 01 | Slovakia |
| Accout Center s.r.o. | Šahy | 936 01 | Slovakia |
| Johese Clinical Research: Unitas | Lyttelton | Centurion | 0157 | South Africa |
| Johese Clinical Research | Midstream | Centurion | 1692 | South Africa |
| Lenasia Clinical Trial Centre | Johannesburg | Gauteng | 1827 | South Africa |
| Dr JP Wright Practice | Cape Town | Western Cape | 7708 | South Africa |
| Kyungpook National University Hospital | Junggu | Daegu | 41944 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | 03722 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Faculty of Medicine Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
| Supaporn Lertkawinanan | Pathum Wan | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
| Ms. Arawan Larplertsakul | Chiang Mai | 50200 | Thailand |
| Uludag University Medical Faculty | Beşevler | Yenimahalle / Ankara | 16059 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06500 | Turkey (Türkiye) |
| Antalya Training and Research Hospital | Antalya | 07030 | Turkey (Türkiye) |
| Kocaeli University Research and Training Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
| I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | 49005 | Ukraine |
| Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University | Ivano-Frankivsk | 76018 | Ukraine |
| Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga | Ivano-Frankivsk | 76018 | Ukraine |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | 61037 | Ukraine |
| Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61058 | Ukraine |
| Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council | Kharkiv | 61124 | Ukraine |
| Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City | Kherson | 73000 | Ukraine |
| Kremenchuk first city hospital n.a. O.T. Bohaievskyi | Kremenchuk | 39617 | Ukraine |
| National Military Medical Clinical Center Main Military Clinical Hospital | Kyiv | 01133 | Ukraine |
| Kyiv City Clinical Hospital N 1 | Kyiv | 02091 | Ukraine |
| Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care | Lviv | 79059 | Ukraine |
| Odesa regional clinical hospital, regional center of gastroenterology, surgical department | Odesa | 65025 | Ukraine |
| A. Novak Transcarpathian Regional Clinical Hospital | Uzhhorod | 88000 | Ukraine |
| Medical Clinical Investigational Center of Medical Center Health Clinic LLC | Vinnytsia | 21009 | Ukraine |
| M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | 21018 | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | 21029 | Ukraine |
| Communal Institution City Clinical Hospital #6, Department of Gastroenterology | Zaporizhzhia | 69035 | Ukraine |
| Barts Health NHS Trust - Whipps Cross University Hospital | London | Greater London | E11 1NR | United Kingdom |
| Guys and St Thomas NHS Foundation Trust | London | Greater London | SE1 9RT | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk | NR4 7UQ | United Kingdom |
| Yeovil Hospital NHS Foundation Trust | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Belfast Health and Social Care Trust Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital | Hemel Hempstead | HP2 4AD | United Kingdom |
| Derived |
| Dubinsky MC, Chaparro M, Irving PM, Hur P, Sidhu S, Woolcott JC, Wang W, Goetsch M, Torres J, Panaccione R. Rapid symptomatic improvement with etrasimod in ulcerative colitis: a post-hoc analysis of the ELEVATE UC program. Inflamm Bowel Dis. 2026 Jun 1;32(6):1075-1085. doi: 10.1093/ibd/izaf333. |
| 40889900 | Derived | Chaparro M, Panaccione R, Sands BE, Irving PM, Goetsch M, Kunina E, Wang W, Wu J, Woolcott JC, Bartolome L, Cognata C, Wosik K, Dubinsky MC. Etrasimod for the symptomatic relief of ulcerative colitis: a post-hoc analysis from the ELEVATE UC clinical programme. BMJ Open Gastroenterol. 2025 Aug 31;12(1):e001838. doi: 10.1136/bmjgast-2025-001838. |
| 40618942 | Derived | Yarur AJ, Reinisch W, Chang S, Gecse KB, Green J, Abbatemarco AM, Wu J, Goetsch M, Lazin K, Pradeep G, Sands BE. Efficacy of Etrasimod in Ulcerative Colitis: Analysis of ELEVATE UC 52 and ELEVATE UC 12 by Baseline Endoscopic Severity. Clin Gastroenterol Hepatol. 2026 Jan;24(1):210-220.e3. doi: 10.1016/j.cgh.2025.06.020. Epub 2025 Jul 4. |
| 40184206 | Derived | Lichtenstein GR, Allegretti JR, Loftus EV Jr, Irving PM, Banerjee R, Charabaty A, Kuehbacher T, Bananis E, Woolcott JC, Dalam AB, Lazin K, Keating M, McDonnell A, Danese S. Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Sep 1;31(9):2352-2362. doi: 10.1093/ibd/izae308. |
| 40036804 | Derived | Sands BE, Dubinsky MC, Kotze PG, Vermeire S, Panaccione R, Long MD, Woolcott JC, Wu J, McDonnell A, Goetsch M, Bananis E, Yarur AJ. Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active Ulcerative Colitis Stratified by Baseline Modified Mayo Score: A Post Hoc Analysis From the Phase 3 ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Oct 1;31(10):2681-2692. doi: 10.1093/ibd/izaf036. |
| 39891572 | Derived | Afzali A, Regueiro M, Yarur AJ, Zabana Y, Ng SC, Menon S, McDonnell A, Lazin K, Keating M, Bhattacharjee A, Branquinho D, Bananis E, Peyrin-Biroulet L. Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With Ulcerative Colitis-A Safety Analysis. United European Gastroenterol J. 2025 Jun;13(5):719-727. doi: 10.1002/ueg2.12745. Epub 2025 Feb 1. |
| 39878434 | Derived | Yarur AJ, Long MD, Torres J, Nandi N, Cross RK, Abbatemarco AM, Blanco D, Niezychowski W, Crosby C, Wu J, Pradeep G, Goetsch M, Panaccione R. Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Analysis of the ELEVATE Ulcerative Colitis Clinical Program. Am J Gastroenterol. 2025 Nov 1;120(11):2611-2622. doi: 10.14309/ajg.0000000000003330. Epub 2025 Jan 29. |
| 39778975 | Derived | Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516. |
| 39671695 | Derived | Yarur AJ, Chiorean MV, Allegretti JR, Cross RK, Ha C, Goetsch M, McDonnell A, Dalam AB, Wu J, Blanco DA, Abbatemarco AM, Panes J. Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program. Inflamm Bowel Dis. 2025 Aug 1;31(8):2144-2153. doi: 10.1093/ibd/izae288. |
| 39526078 | Derived | Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024. |
| 39326009 | Derived | Armuzzi A, Rubin DT, Schreiber S, Panes J, Fellmann M, Bartolome L, Gruben D, Goetsch M, Bhattacharjee A, Chaparro M, Dubinsky MC. Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients With Ulcerative Colitis: A Post Hoc Analysis of Data From ELEVATE UC 52 and ELEVATE UC 12. Inflamm Bowel Dis. 2025 Jun 13;31(6):1583-1594. doi: 10.1093/ibd/izae229. |
| 39306680 | Derived | Sands BE, Leung Y, Rubin DT, Gecse KB, Panes J, Goetsch M, Wang W, Woolcott JC, Smith CC, Wosik K, Schreiber S. Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids on Efficacy and Safety, and Corticosteroid-Sparing Effect in Ulcerative Colitis: Analyses of the ELEVATE UC Clinical Program. J Crohns Colitis. 2025 Mar 5;19(3):jjae150. doi: 10.1093/ecco-jcc/jjae150. |
| 39089519 | Derived | Magro F, Peyrin-Biroulet L, Sands BE, Danese S, Jairath V, Goetsch M, Bhattacharjee A, Wu J, Branquinho D, Modesto I, Feagan BG. Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod. Clin Gastroenterol Hepatol. 2025 Feb;23(2):341-350.e6. doi: 10.1016/j.cgh.2024.07.010. Epub 2024 Jul 31. |
| 38877972 | Derived | Vermeire S, Sands BE, Peyrin-Biroulet L, D'Haens GR, Panes J, Yarur AJ, Wolf DC, Ritter T, Schreiber S, Woolcott JC, Modesto I, Keating M, Shan K, Wu J, Chiorean MV, Baert F, Dubinsky MC, Goetsch M, Danese S, Feagan BG. Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials. J Crohns Colitis. 2024 Nov 4;18(11):1780-1794. doi: 10.1093/ecco-jcc/jjae079. |
| 38700040 | Derived | Regueiro M, Siegmund B, Yarur AJ, Steinwurz F, Gecse KB, Goetsch M, Bhattacharjee A, Wu J, Green J, McDonnell A, Crosby C, Lazin K, Branquinho D, Modesto I, Abreu MT. Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events from the ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Oct 15;18(10):1596-1605. doi: 10.1093/ecco-jcc/jjae060. |
| 38613425 | Derived | Peyrin-Biroulet L, Dubinsky MC, Sands BE, Panes J, Schreiber S, Reinisch W, Feagan BG, Danese S, Yarur AJ, D'Haens GR, Goetsch M, Wosik K, Keating M, Lazin K, Wu J, Modesto I, McDonnell A, Bartolome L, Vermeire S. Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme. J Crohns Colitis. 2024 Aug 14;18(8):1270-1282. doi: 10.1093/ecco-jcc/jjae038. |
| 36871574 | Derived | Sandborn WJ, Vermeire S, Peyrin-Biroulet L, Dubinsky MC, Panes J, Yarur A, Ritter T, Baert F, Schreiber S, Sloan S, Cataldi F, Shan K, Rabbat CJ, Chiorean M, Wolf DC, Sands BE, D'Haens G, Danese S, Goetsch M, Feagan BG. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet. 2023 Apr 8;401(10383):1159-1171. doi: 10.1016/S0140-6736(23)00061-2. Epub 2023 Mar 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etrasimod 2 mg | Etrasimod 2 mg was administered orally once daily for up to 52 weeks. |
| BG001 | Placebo | Placebo was administered orally once daily for up to 52 weeks. |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Percentage of Participants Achieving Clinical Remission at Week 12 | Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS (consisting of all randomized participants who received at least 1 dose of study treatment) with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Clinical Remission at Week 52 | Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Improvement at Week 12 | Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Improvement at Week 52 | Endoscopic improvement was defined as an ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Remission at Week 12 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Remission at Week 52 | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mucosal Healing at Week 12 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mucosal Healing at Week 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52 | Corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, ES ≤ 1 (excluding friability), and have not received corticosteroids for ≥ 12 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52 | Sustained clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability) at both Week 12 and Week 52. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 12 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response at Week 12 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response at Week 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB sub-score ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52 | Clinical response was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 12 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52 | Mucosal healing was defined as an ES ≤ 1 (excluding friability) with histologic remission measured by a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 12 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Normalization at Week 12 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Normalization at Week 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52 | Endoscopic normalization was defined as an ES = 0. The ES ranged from 0 to 3 (where 0= normal/inactive disease and 3= severe disease). | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 12 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Remission by Study Visit | Symptomatic remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline) and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit | Complete symptomatic remission was defined as an SF subscore = 0 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit | Non-invasive clinical response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores, and a ≥ 1-point decrease from Baseline in RB subscore or RB subscore ≤ 1. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Symptomatic Response by Study Visit | Symptomatic response was defined as a ≥ 30% decrease from Baseline in composite RB and SF subscores. The SF subscore ranged from 0 to 3 (where 0= normal number of stools and 3= at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0= no blood and 3= blood alone passes). The composite RB and SF score range was from 0 to 6, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. | Posted | Number | Percentage of participants | At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline | Four-week corticosteroid-free clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1, and have not received corticosteroids for ≥ 4 weeks in the 40-Week Treatment Period. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. Only participants receiving corticosteroids at study entry and who had not been receiving corticosteroids for ≥ 4 weeks prior to Week 52 were included in this analysis. | Posted | Number | Percentage of participants | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12 | Clinical remission and clinical response were based on the MMS which is a composite of 3 assessments: SF, RB and ES. Clinical remission was defined as an SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Clinical response was defined as a ≥ 2-point and ≥ 30% decrease from Baseline MMS, and a ≥ 1-point decrease from Baseline in RB subscore or an absolute RB subscore ≤ 1. Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. | FAS with actual Baseline MMS 5 to 9. Only participants in clinical response at Week 12 were included in this analysis. | Posted | Number | Percentage of participants | At Week 52 |
|
|
Up to 56 weeks (12-Week and 40-Week Treatment Periods plus Follow-up). Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment up to 30 days following discontinuation of the study treatment.
TEAEs, defined as those adverse events that started or worsened in severity after the first dose of study treatment, are reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment.
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 | Etrasimod 2 mg | Etrasimod 2 mg was administered orally once daily for up to 52 weeks. | 0 | 289 | 20 | 289 | 204 | 289 |
| EG001 | Placebo | Placebo was administered orally once daily for up to 52 weeks. | 0 | 144 | 9 | 144 | 77 | 144 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mucosal prolapse syndrome | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Breast conserving surgery | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Anembryonic gestation | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Acne pustular | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Ear infection staphylococcal | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mucosal prolapse syndrome | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Small intestine polyp | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood triglycerides abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Urine ketone body | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Spirometry abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| FEV1/FVC ratio decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lung diffusion test decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary arterial pressure decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asterixis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ankle deformity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypocoagulable state | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lipomatosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alopecia scarring | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ephelides | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Purpura senile | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Xanthelasma | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Amblyopia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Astigmatism | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eyelid pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eyelid cyst | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Injury corneal | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Primary biliary cholangitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Micturition frequency decreased | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Penile curvature | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arena CT.gov Administrator | Arena Pharmaceuticals, a wholly owned subsidiary of Pfizer | +1 855-218-9153 | ct.gov@arenapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2022 | Nov 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|