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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004435-72 | EudraCT Number |
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The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.
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This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Open-label Extension | Experimental | Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE). |
|
| Part 2: Safety Monitoring | No Intervention | All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrolizumab | Drug | Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off. | Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks |
| Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) | The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off. | At OLE Week 108 |
| Part 1: Percentage of Participants With Endoscopic Remission | The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off. | At OLE Week 108 |
| Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] |
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Inclusion Criteria:
Part 1 (Open-label Extension)
- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
Part 2 (Safety Monitoring)
Exclusion Criteria:
Part 1 (Open-label Extension)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Medical Center | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32445184 | Derived | Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22. |
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This study consists of two parts, Part 1: Open-label extension (OLE) period and Part 2: Progressive multifocal leukoencephalopathy (PML) safety monitoring (SM) period. A total of 1822 participants with ulcerative colitis (UC) were enrolled in the study, 1773 participants in Part 1 and 796 participants in Part 2. Of the 796, 49 participants were directly enrolled into the Part 2: PML SM period from their respective parent studies.
Participants took part in this study in 42 countries. All participants who were enrolled in this study previously took part in one of the following parent studies - Phase II: GA27927; Phase III: GA28948, GA28949, GA28950, GA29102, GA29103.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 (OLE): Etrolizumab Only | Participants received etrolizumab 105 milligrams (mg), subcutaneously (SC) every 4 weeks (Q4W) for maximum of 369.9 weeks, followed by a 12-week safety follow-up. |
| FG001 | Part 1 (OLE) to Part 2 (PML SM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Open Label Extension Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2019 | Sep 30, 2024 |
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An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. |
| From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Serious Infection Related AES | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Malignancies | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period | From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks |
| La Jolla |
| California |
| 92093-5354 |
| United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| SDG Clinical Research | San Diego | California | 92103 | United States |
| University of California at San Francisco | San Francisco | California | 94115 | United States |
| Ventura Clinical Trials | Ventura | California | 93003 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Clinical Research of the Rockies | Lafayette | Colorado | 80026 | United States |
| Rocky Mountain Gastroenterology Associates | Wheat Ridge | Colorado | 80033 | United States |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33756 | United States |
| Regenerate Clinical Trials | Miami | Florida | 33155 | United States |
| IMIC, Inc | Miami Beach | Florida | 33140 | United States |
| FQL Research, LLC | Miramar | Florida | 33025 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center; Medicine, Section of Pulmonary | Chicago | Illinois | 60637 | United States |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | United States |
| Aquiant Research | New Albany | Indiana | 47150 | United States |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | United States |
| Massachusetts General Hospital; Crohn's & Colitis Center | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | United States |
| Kansas City Research Institute, LLC | Kansas City | Missouri | 64131 | United States |
| Clinica Peruano Americana S.A. | Great Neck | New York | 11021 | United States |
| NYU Langone Medical Center | New York | New York | 10016-9451 | United States |
| Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) | New York | New York | 10021 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Consultants for Clin. Rsrch | Cincinnati | Ohio | 45219 | United States |
| UC Health Clinical Trials Office; Division of Digestive Diseases | Cincinnati | Ohio | 45267 | United States |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | United States |
| Gastroenterology Center of the Midsouth, P.C. | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | United States |
| Wellness Clinical Research Center | San Antonio | Texas | 78232 | United States |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Ericksen Research and Development | Clinton | Utah | 84015 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | United States |
| McGuire Research Institute; Gastroenterology | Richmond | Virginia | 23249 | United States |
| Washington Gastroenterology | Bellevue | Washington | 98004 | United States |
| Instituto Medico DAMIC | Córdoba | X5003DCE | Argentina |
| Hospital Provincial del Centenario | Rosario | S2002KDS | Argentina |
| Bankstown-Lidcombe Hospital | Bankstown | New South Wales | 2200 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Adult Hospital | Mackay | Queensland | 4740 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Launceston General Hospital; Gastroenterology Research | Launceston | Tasmania | 7250 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Footscray Hospital | Footscray | Victoria | 3011 | Australia |
| St Frances Xavier Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics | Parkville | Victoria | 3050 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| GZA Ziekenhuizen - Campus Sint-Vincentius | Antwerp | 2018 | Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| CHU St Pierre (St Pierre) | Brussels | 1000 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc; Pharmacy | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Sint Elisabeth Herentals | Herentals | 2200 | Belgium |
| UZ Leuven; Neurology | Leuven | 3000 | Belgium |
| AZ Delta (Campus Rumbeke) | Roeselare | 8800 | Belgium |
| Hospital Universitario Walter Cantidio - UFC | Fortaleza | Ceará | 60430-370 | Brazil |
| Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia | Salvador | Estado de Bahia | 41110-170 | Brazil |
| CCBR - Brasilia | Brasília | Federal District | 70200-730 | Brazil |
| Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiânia | Goiás | 74535-170 | Brazil |
| Hospital Felicio Rocho | Belo Horizonte | Minas Gerais | 30110-068 | Brazil |
| Centro Digestivo de Curitiba | Curitiba | Paraná | 80430-160 | Brazil |
| Hospital Universitario Clementino Fraga Filho - UFRJ | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | Rio Grande do Sul | 90160-092 | Brazil |
| UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu | São Paulo | 18618-970 | Brazil |
| CAEP - Centro Avancado de Estudos e Pesquisas Ltda. | Campinas | São Paulo | 13087-567 | Brazil |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Jaú | São Paulo | 17210-190 | Brazil |
| Pesquisare Saúde Sociedade Simples | Santo André | São Paulo | 09080-000 | Brazil |
| Hospital Estadual Mario Covas | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Hospital Sírio-Libanês | São Paulo | São Paulo | 01308-050 | Brazil |
| Hospital do Servidor Público Estadual/HSPE-SP | São Paulo | São Paulo | 04039-901 | Brazil |
| Medical Centre "Asklepii", OOD | Dupnitsa | 2600 | Bulgaria |
| DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology | Pleven | 5800 | Bulgaria |
| Medical center Medconsult Pleven OOD | Pleven | 5800 | Bulgaria |
| MHAT - Ruse, AD | Rousse | 7002 | Bulgaria |
| MHAT "Hadzhi Dimitar", OOD | Sliven | 8800 | Bulgaria |
| "City Clinic UMHAC" EOOD | Sofia | 1407 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | 1431 | Bulgaria |
| UMHAT Tsaritsa Yoanna - ISUL, EAD | Sofia | 1527 | Bulgaria |
| Diagnostic Consultation Center CONVEX EOOD | Sofia | 1680 | Bulgaria |
| Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora | 6000 | Bulgaria |
| MHAT 'Sv. Marina', EAD; First Children's Clinic | Varna | 9010 | Bulgaria |
| MC Medica Plus | Veliko Tarnovo | 5000 | Bulgaria |
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology | Edmonton | Alberta | T6G 2X8 | Canada |
| Pacific Gastroenterology Associates | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Queen Elizabeth II Health Sciences Centre; Gastroenterology Research | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Guelph GI & Surgery Clinic | Guelph | Ontario | N1H 3R3 | Canada |
| University Hospital - London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Taunton Health Centre | Oshawa | Ontario | L1H 7K4 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto Digestive Disease Associates | Vaughan | Ontario | L4L 4Y7 | Canada |
| Centre de santé et de services sociaux Champlain-Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hotel Dieu de Levis | Lévis | Quebec | G6V 3Z1 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| RTS - Fundación Valle de Lili | Cali | 0 | Colombia |
| Instituto de Coloproctologia ICO S.A.S. | Medellín | 050025 | Colombia |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| Clinical Hospital Sveti Duh; Department of Neurology | Zagreb | 10000 | Croatia |
| Vojenska nemocnice Brno | Brno | 636 00 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika | Brno | 65691 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum | Kladno | 272 59 | Czechia |
| PreventaMed, s.r.o. | Olomouc | 779 00 | Czechia |
| Mestska Nemocnice Ostrava | Ostrava | 728 80 | Czechia |
| Pardubicka krajska nemocnice a.s. | Pardubice | 532 03 | Czechia |
| ISCARE a.s. | Prague | 170 04 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 01 | Czechia |
| Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni | Ústí nad Labem | 401 13 | Czechia |
| Krajska nemocnice T. Bati, a.s. | Zlín | 76001 | Czechia |
| Ålborg Universitets Hospital; Gastromedicinsk | Aalborg | 9000 | Denmark |
| Herlev og Gentofte Hospital | Hellerup | 2900 | Denmark |
| Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme | København Ø | 2100 | Denmark |
| OÜ Innomedica | Tallinn | 10117 | Estonia |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| CHU Amiens - Hopital Sud | Amiens | 80054 | France |
| CHU de Caen Hopital Cote de Nacre | Caen | 14033 | France |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | 37170 | France |
| Hôpital Beaujon | Clichy | 92110 | France |
| Hopital Claude Huriez - CHU Lille | Lille | 59037 | France |
| CHU Hopital Saint Eloi | Montpellier | 34295 | France |
| CHU Nice - Hopital de l'Archet 2 | Nice | 06202 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| CHU Bordeaux - Hôpital Haut-Lévêque | Pessac | 33600 | France |
| Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie | Pierre-Bénite | 69495 | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| Höpital Hautepierre; Pediatrie1 | Strasbourg | 67098 | France |
| CHU de Toulouse - Hôpital Rangueil | Toulouse | 31059 | France |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | 54511 | France |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 10117 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| DRK Kliniken Berlin Westend | Berlin | 14050 | Germany |
| Krankenhaus Waldfriede e. V. | Berlin | 14163 | Germany |
| Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH | Bochum | 44789 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91054 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | 60590 | Germany |
| Universitaetsklinikum Freiburg; Urology | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Hamburgisches Forschungsinstitut fuer CED | Hamburg | 20148 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Gastroenterologie Eppendorfer Baum | Hamburg | 20249 | Germany |
| Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie | Hanover | 30625 | Germany |
| Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena | Jena | 07740 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24116 | Germany |
| Medizinisches Zentrum Klinikum Lueneburg | Lüneburg | 21339 | Germany |
| Klinikum Mannheim GmbH Universitätsklinikum | Mannheim | 68167 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt | Schweinfurt | 97421 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| University General Hospital of Heraklion | Heraklio | 711 10 | Greece |
| University of Hong Kong | Hong Kong | Hong Kong |
| DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | 8230 | Hungary |
| Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza | Békéscsaba | 5600 | Hungary |
| Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika | Budapest | 1088 | Hungary |
| Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo | Budapest | 1125 | Hungary |
| Pannónia Klinika Magánorvosi | Budapest | 1136 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | H-1077 | Hungary |
| Endomedix Diagnosztikai Kozpont | Budapest | Hungary |
| Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | Debrecen | 4025 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Markhot Ferenc Oktato Korhaz es Rendelointezet | Eger | 3300 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Miskolc | 3526 | Hungary |
| Pecsi Tudomanyegyetem | Pécs | 7624 | Hungary |
| Csongrad Megyei Dr. Bugyi Istvan Korhaz | Szentes | 6600 | Hungary |
| Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár | 8000 | Hungary |
| Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology | Hyderabad | Andhra Pradesh | 500058 | India |
| Nirmal Hospital | Surat | Gujarat | 395002 | India |
| K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre | Belagavi | Karnataka | 590010 | India |
| M. S. Ramaiah Medical College and Hospital | Bengaluru | Karnataka | 560054 | India |
| Kasturba Medical College & Hospital | Manglore | Karnataka | 575001 | India |
| Midas institute of Gastroenterology | Nagpur | Maharashtra | 440012 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Dayanand Medical College and Hospital | Ludhiana | Punjab | 141001 | India |
| S. R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| King Edward Memorial Hospital Research Centre | Pune | 411011 | India |
| Bnai Zion Medical Center; Internal Medicine | Haifa | 3339419 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Holy Family Hospital | Nazareth | 1641101 | Israel |
| Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute | Petach Tiqwa | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 7610001 | Israel |
| Assaf Harofeh | Rishon LeZiyyon | 7505001 | Israel |
| Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit | Tel Litwinsky | 52621 | Israel |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh | Bologna | Emilia-Romagna | 40138 | Italy |
| A.O.U. Policlinico di Modena | Modena | Emilia-Romagna | 40124 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43126 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Ospedale Sandro Pertini | Rome | Lazio | 00157 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 151 | Italy |
| Fondazione Poliambulanza Istituto Ospedaliero | Brescia | Lombardy | 25124 | Italy |
| Azienda Ospedaliera Fatebenefratelli e Oftalmico | Milan | Lombardy | 20121 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Milan | Lombardy | 20162 | Italy |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milan | Lombardy | Italy |
| Ospedale di Circolo; Neuropsichiatria Infantile | Rho | Lombardy | 20017 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI) | Lombardy | 20097 | Italy |
| IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest | San Giovanni Rotondo | Lombardy | 71013 | Italy |
| Ospedale Mauriziano Umberto I | Turin | Piedmont | 10128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Sicily | 90127 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| Central Outpatient Clinic | Daugavpils | LV-5401 | Latvia |
| Pauls Stradins Clinical University Hospital | R?ga | LV-1002 | Latvia |
| Digestive Diseases Center "Gastro" | R?ga | LV-1079 | Latvia |
| Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas | 50009 | Lithuania |
| Klaipeda Seamen's Hospital, Public Institution | Klaipėda | 92288 | Lithuania |
| Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology | Vilnius | LT-08661 | Lithuania |
| Pusat Perubatan Universiti Kebangsaan Malaysia | Kuala Lumpur | FED. Territory of Kuala Lumpur | 56000 | Malaysia |
| University Malaya Medical Center | Kuala Lumpur | FED. Territory of Kuala Lumpur | 59100 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Raja Perempuan Zainab II; Department of Medicine | Kota Bharu | 15586 | Malaysia |
| Centro Integral en Reumatología S.A. de C.V. (CIRSA) | Guadalajara | Jalisco | 44160 | Mexico |
| Accelerium S. de R.L. de C.V. | Monterrey | Nuevo León | 64000 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León | Monterrey | Nuevo León | 64460 | Mexico |
| Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey | Nuevo León | 64610 | Mexico |
| Phylasis Clinicas Research S de RL de CV | Cuautitlán Izcalli | 54769 | Mexico |
| Amsterdam UMC Location VUMC | Amsterdam | 1081 HV | Netherlands |
| Amsterdam UMC Location AMC | Amsterdam | 1105 AZ | Netherlands |
| Radboudumc | NL -nijmegen | 6525 GA | Netherlands |
| North Shore Hospital | Auckland | 0620 | New Zealand |
| Middlemore Hospital | Auckland | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Waikato Hospital | Hamilton | 3248 | New Zealand |
| Shakespeare Specialist Group | Takapuna | 0620 | New Zealand |
| Tauranga Hospital | Tauranga | 3143 | New Zealand |
| Akershus universitetssykehus HF | Lørenskog | 1478 | Norway |
| AppleTreeClinics Sp. z o.o. | ?ód? | 90-349 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | 85-312 | Poland |
| Centrum Medyczne Lukamed Joanna Luka | Chojnice | 89-600 | Poland |
| Centrum Medyczne Sw. Lukasza | Cz?stochowa | 42-202 | Poland |
| 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego | Gdansk | 80-305 | Poland |
| Pro Familia Altera Sp z o.o. | Katowice | 40-645 | Poland |
| Nzoz All-Medicus | Katowice | 40-660 | Poland |
| Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM | Katowice | 40-752 | Poland |
| NZOZ Centrum Medyczne ProMiMed | Krakow | 31-637 | Poland |
| Centrum Opieki Zdrowotnej Orkan-Med | Ksawerów | 95-054 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska | Lublin | 20-015 | Poland |
| GASTROMED Sp. z o.o. | Lublin | 20-582 | Poland |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. | Nowy Targ | 34-400 | Poland |
| Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | 10-561 | Poland |
| SOLUMED Centrum Medyczne | Późna | 60-529 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-055 | Poland |
| Gabinet Lekarski, Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia | Sopot | 81-756 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej SONOMED | Szczecin | 70-351 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-189 | Poland |
| Zespó Przychodni Specjalistycznych PRIMA | Warsaw | 02-018 | Poland |
| Endoterapia PFG Sp. z o.o. | Warsaw | 02-653 | Poland |
| Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Nzoz Vivamed | Warsaw | 03-580 | Poland |
| Przychodnia EuroMediCare | Wroc?aw | 50-220 | Poland |
| PlanetMed | Wroc?aw | 52-210 | Poland |
| LexMedica Osrodek Badan Klinicznych | Wroclaw | 53-114 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital da Senhora da Oliveira Guimarães | Guimarães | 4835-044 | Portugal |
| S.C MedLife S.A | Bucharest | 010719 | Romania |
| Centrul Medical Unirea SRL | Bucharest | 040055 | Romania |
| Spitalul Clinic Colentina | Bucharest | 772202 | Romania |
| Centrul de Gastroenterologie Dr. Goldis | Timișoara | 300002 | Romania |
| Yusupov Hospital | Moskva | Adygeya Republic | 127015 | Russia |
| SBEI HPE Altai StateMedicalUniversityofMoH andSD | Barnaul | Altayskiy Kray | 656050 | Russia |
| FSBIH Central Clinical Hospital of RAS | Moscow | Moscow Oblast | 119333 | Russia |
| FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology | Moscow | Moscow Oblast | 123154 | Russia |
| SBHI of NN region ?RCH of NN n.a. N.A.Semashko? | Nizhny Novgorod | Niznij Novgorod | 603126 | Russia |
| SEIHPE "Rostov SMU of MoH of RF" | Rostov-on-Don | Rostov Oblast | 344022 | Russia |
| FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy | Saint Petersburg | Sankt-Peterburg | 193163 | Russia |
| FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology | Saint Petersburg | Sankt-Peterburg | 194044 | Russia |
| SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery | Saint Petersburg | Sankt-Peterburg | 194354 | Russia |
| Baltic Medicine | Saint Petersburg | Sankt-Peterburg | 194356 | Russia |
| City Hospital #26 | Saint Petersburg | Sankt-Peterburg | 196247 | Russia |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| SBIH City Clinical Hospital #31 | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| SPb SHI "City Hospital #9" | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| LLC International Medical Centre ?SOGAZ? | Saint Petersburg | Sankt-Peterburg | 198035 | Russia |
| Medical and Sanitary Division of Severstal | Cherepovets | Vologda Oblast | 162600 | Russia |
| SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF | Voronezh | Voronez | 394036 | Russia |
| Irkutsk State Medical Academy of Continuing Education | Irkutsk | 664079 | Russia |
| FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS | Novosibirsk | 630117 | Russia |
| BHI of Omsk region Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| SBEI of HPE "Omsk SMA" Ministry of healthcare of RF" | Omsk | 644043 | Russia |
| Stavropol Regional Clinical Diagnostic Consultative Center | Stavropol | 355017 | Russia |
| FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation | Stavropol | 355018 | Russia |
| Clinical Center Zvezdara | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11040 | Serbia |
| Clinical Center Zemun | Belgrade | 11080 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| General Hospital Djordje Joanovic | Zrenjanin | 23000 | Serbia |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banská Bystrica | 974 01 | Slovakia |
| Nemocnica A.Lena Humenne, n.o. | Humenné | 066 01 | Slovakia |
| Endomed, s.r.o. | Košice | 040 01 | Slovakia |
| KM Management spol. s r.o. | Nitra | 94901 | Slovakia |
| Gastro I, s.r.o. | Prešov | 080 01 | Slovakia |
| Svet zdravia a.s. | Rimavská Sobota | 979 01 | Slovakia |
| Accout Center s.r.o. | Šahy | 936 01 | Slovakia |
| Netcare Universitas Private Hospital | Bloemfontein | 9301 | South Africa |
| Dr MJ Prins Practice | Cape Town | 7500 | South Africa |
| Dr JP Wright Practice | Cape Town | 7708 | South Africa |
| Emmed Research | Pretoria | 0002 | South Africa |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Yeungnam Univ. Hospital | Daegu | 705-717 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| CHA Bundang Medical Centre; CHA university | Seongnam | 13520 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Asan Medical Center. | Seoul | 5505 | South Korea |
| The Catholic University of Korea St. Vincent's Hospital | Suwon | 442-723 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Fundacion Hospital de Alcorcon; Servicio de Digestivo | Alcorcón | Madrid | 28922 | Spain |
| Centro Médico Teknon | Barcelona | Spain |
| Hospital Universitari de Girona Dr Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario de Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Inselspital-Universitaetsspital Bern | Bern | 3010 | Switzerland |
| Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner | Bern | 3012 | Switzerland |
| Gazi University Medical Faculty; Gastroenterology | Ankara | 06500 | Turkey (Türkiye) |
| Haydarpasa Numune Training and Research Hospital; Medical Oncology | Istanbul | 34668 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi; Infectious Diseases | Kocaeli | 41380 | Turkey (Türkiye) |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | Kharkiv Governorate | 61037 | Ukraine |
| Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | Kharkiv Governorate | 61058 | Ukraine |
| Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital | Kyiv | Kharkiv Governorate | 04107 | Ukraine |
| CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI | Sumy | Kharkiv Governorate | 40022 | Ukraine |
| LLC Gastroenterology Center IBD Team | Zaporizhzhia | Kharkiv Governorate | 69000 | Ukraine |
| CNE Kyiv CCH #18 | Kyiv | KIEV Governorate | 01030 | Ukraine |
| CI of Kyiv RC Kyiv Regional Clinical Hospital | Kyiv | KIEV Governorate | 04107 | Ukraine |
| Medical Center of Limited Liability Company Medical Clinic Blagomed | Kyiv | KIEV Governorate | 1023 | Ukraine |
| Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" | Kyiv | KIEV Governorate | 2091 | Ukraine |
| CI of Kyiv RC Regional Clinical Hospital #2 | Kyiv | KIEV Governorate | 4073 | Ukraine |
| Lviv Regional Clinical Hospital | Lviv | KIEV Governorate | 79010 | Ukraine |
| CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training | Uzhhorod | KIEV Governorate | 88009 | Ukraine |
| A.Novak Transcarpathian Regional Clinical Hospital | Uzhhorod | KIEV Governorate | 88018 | Ukraine |
| RCNECRCH Dept of Surgery, SHEI Ukr BSMU | Chernivtsi | Podolia Governorate | 58002 | Ukraine |
| CI City Hospital #1 | Zaporizhzhia | Tavria Okruha | 69104 | Ukraine |
| RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU | Chernivtsi | 58002 | Ukraine |
| SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU | Dnipropetrovsk | 49074 | Ukraine |
| GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine | Kharkiv | 61039 | Ukraine |
| CI of Healthcare Kharkiv CCH #13 | Kharkiv | 61124 | Ukraine |
| CI Kherson Afanasii and Olha Tropiny City Clinical Hospital | Kherson | 73000 | Ukraine |
| CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv | Kyiv | 02232 | Ukraine |
| Odessa regional clinical Hospital | Odesa | 65117 | Ukraine |
| M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA | Poltava | 36011 | Ukraine |
| M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy | Poltava | 36011 | Ukraine |
| Private Small Enterprise Medical Center Pulse | Vinnytsia | 21001 | Ukraine |
| M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | 21018 | Ukraine |
| MCIC Health Clinic BO LTD TPC Slaomed | Vinnytsia | 21029 | Ukraine |
| Co Ltd. Diaservice | Zaporizhzhia | 69035 | Ukraine |
| CI City Hospital #7 | Zaporizhzhia | 69118 | Ukraine |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | EX2 5DW | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| The Royal London Hospital | London | E1 1FR | United Kingdom |
| University College London Hospital | London | N7 9NH | United Kingdom |
| St Thomas Hospital | London | SE1 7EH | United Kingdom |
| King's College London | London | SE5 9NU | United Kingdom |
| Fairfield General Hospital | Manchester | M8 5RB | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham University Hospitals; QMC Campus | Nottingham | NG7 2UH | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up in the OLE period. After the OLE period, participants were given the option to enter Part 2 (PML SM). Participants who chose to enter the PML SM period were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. |
| FG002 | Part 2 (PML SM) Only | Participants from the Phase II or Phase III studies who were not eligible/did not wish to enroll in Part 1 (OLE), and had completed the 12-week safety follow-up period in their parent study were enrolled directly in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2: PML Safety Monitoring Period |
|
|
All Patients Population included all participants who were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 (OLE): Etrolizumab Only | Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up. |
| BG001 | Part 1 (OLE) to Part 2 (PML SM) | Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up in the OLE period. After the OLE period, participants were given the option to enter Part 2 (PML SM). Participants who chose to enter the PML SM period were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. |
| BG002 | Part 2 (PML SM) Only | Participants from the Phase II or Phase III studies who were not eligible/did not wish to enroll in Part 1 (OLE), and had completed the 12-week safety follow-up period in their parent study were enrolled directly in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) | The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) | The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | At OLE Week 108 |
|
| |||||||||||||||||||||||||||||
| Primary | Part 1: Percentage of Participants With Endoscopic Remission | The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | At OLE Week 108 |
|
| |||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] | An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
| ||||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
|
| |||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
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| Primary | Part 1: Number of Participants With Serious Infection Related AES | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
|
| |||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
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| Primary | Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
|
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| Primary | Part 1: Number of Participants With Malignancies | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
|
| |||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. | OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years) |
|
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| Primary | Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period | PML Safety Monitoring population included all participants who entered the PML SM period. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together. | Posted | Count of Participants | Participants | From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks |
|
|
Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks
OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
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 | Part 1 (OLE): Etrolizumab | Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up. | 9 | 1,773 | 373 | 1,773 | 1,052 | 1,773 |
| EG001 | Part 2 (PML SM) | Participants from Part 1 (OLE) and from Phase II/III studies who were not eligible/did not wish to enroll in Part 1 (OLE) and had completed the 12-week safety follow-up period were enrolled in the Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. | 1 | 796 | 2 | 796 | 2 | 796 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Leukaemoid reaction | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Paroxysmal atrioventricular block | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Tethered oral tissue | Congenital, familial and genetic disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colon dysplasia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal dysplasia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal polyp | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Malocclusion | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Strangulated umbilical hernia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bacterial salpingitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Focal peritonitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Meningitis listeria | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tuberculous pleurisy | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Epidural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Epiphyseal fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Spondylolysis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Seronegative arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Tendon laxity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Intraductal papillary breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Ovarian stromal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of pharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Tumour perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA version 26.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 26.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA version 26.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA version 26.1 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Paraphimosis | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Granuloma skin | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2022 | Sep 30, 2024 | 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 |
|---|---|
| C559198 | etrolizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Non-Compliance |
|
| Reason Not Specified |
|
| Physician Decision |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| Multiple |
|
| Unknown |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Week 60 |
|
|
| Week 72 |
|
|
| Week 84 |
|
|
| Week 96 |
|
|
| Week 108 |
|
|
| Week 120 |
|
|
| Week 132 |
|
|
| Week 144 |
|
|
| Week 156 |
|
|
| Week 168 |
|
|
| Week 180 |
|
|
| Week 192 |
|
|
| Week 204 |
|
|
| Week 216 |
|
|
| Week 228 |
|
|
| Week 240 |
|
|
| Week 252 |
|
|
| Week 264 |
|
|
| Week 276 |
|
|
| Week 288 |
|
|
| Week 300 |
|
|
| Week 312 |
|
|
| Week 324 |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|