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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003855-76 | 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 open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Etrolizumab Open-Label Extension | Experimental | Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled). |
|
| Part 2: Safety Monitoring | No Intervention | Participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrolizumab | Drug | 105 mg etrolizumab subcutaneous administration once every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission. | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE |
| Part 1: Number of Participants With Clinical Remission at 12-week Intervals | Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain (AP) mean daily score ≤1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces. | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE |
| Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 | SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as ≥50% reduction in SES-CD score compared to baseline. |
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Inclusion Criteria:
Part 1 Open-Label Extension:
Part 2 Safety Monitoring:
Exclusion Criteria:
Part 1 Open-Label Extension:
Part 2 Safety Monitoring:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Gastroenterology Consultants | Arcadia | California | 91006 | 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 2 parts, Part 1: Open-label extension (OLE) period & Part 2: Progressive multifocal leukoencephalopathy (PML) safety monitoring (SM) period. A total of 790 participants were enrolled in the study, 751 participants in Part 1 and 359 participants in Part 2. Of the 359, 39 participants directly entered into the Part 2 PML SM period from study GA29144.
Participants were enrolled in this study in 33 countries. All participants who enrolled into this study previously took part in study GA29144 (NCT02394028).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 (OLE): Etrolizumab Only | Participants received etrolizumab 105 milligrams (mg), subcutaneously (SC), once every 4 weeks (Q4W) for a maximum of 320 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 | Apr 29, 2019 | Oct 8, 2024 |
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| At OLE Week 108 |
| Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as 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 a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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 AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once. | From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 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 6.3 years) |
| Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AEs were graded 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. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade. | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
| Part 1: Incidence Rate of Infection-related Adverse Event | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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. AE rate (per 100 participant years) = [Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable). | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 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 6.3 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 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 safety 12-week follow-up in OLE (approximately 6.3 years) |
| Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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 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 6.3 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 6.3 years) |
| Part 1: Incidence Rate of Malignancies | Malignancy rate (per 100 participant years) = [Total number of malignancies (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable). | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
| Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 | Hypersensitivity was reported using the MedDRA anaphylactic reaction standard MedDRA query (SMQ) and Sampson's criteria. 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 6.3 years) |
| Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML) | PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation). | From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks |
| La Jolla |
| California |
| 92093-5354 |
| United States |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| Digestive Care Associates, A Medical Corporation | San Carlos | California | 94070 | United States |
| SDG Clinical Research | San Diego | California | 92103 | United States |
| Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri | San Francisco | California | 94158 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Innovative Medical Research of South Florida | Aventura | Florida | 33180 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33756 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| IMIC, Inc | Miami Beach | Florida | 33140 | United States |
| FQL Research, LLC | Miramar | Florida | 33025 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Atlanta Center for Gastroenterology, PC | Decatur | Georgia | 30033 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Advanced Clinical Research | Spokane | Idaho | 99202 | United States |
| Northwestern Uni-Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801-2500 | 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 |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Gastroenterology Associates of Western Michigan, P.L.C. | Grand Rapids | Michigan | 49506 | United States |
| Henry Ford Health System | Novi | Michigan | 48377-3600 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | United States |
| Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston | Kinston | North Carolina | 28501 | United States |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | United States |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | United States |
| Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | 73112 | United States |
| Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | 17110 | United States |
| Innovative Clinical Research | Greenville | South Carolina | 29604 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center; Internal Medicne | Dallas | Texas | 75390-9151 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Wellness Clinical Research Center | San Antonio | Texas | 78232 | United States |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | United States |
| Digestive Health Specialists of Tyler | 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 |
| Digestive Disease Institute; Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Hospital Italiano | CABA | C1199ABB | Argentina |
| The Canberra Hospital | Garran | Australian Capital Territory | 2065 | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| University of the Sunshine Coast | Sippy Downs | Queensland | 4556 | Australia |
| Mater Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | 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 |
| The Alfred Hospital | Prahan | Victoria | 3181 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | 5020 | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| CHU St Pierre (César de Paepe) X | Brussels | 1000 | Belgium |
| ULB Hopital Erasme; Service de Néphrologie | Brussels | 1070 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| 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 |
| Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A | Rio de Janeiro | Rio de Janeiro | 22271-100 | Brazil |
| Hospital Sao Vicente de Paulo | Passo Fundo | Rio Grande do Sul | 99010-090 | 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 |
| Pesquisare Saúde Sociedade Simples | Santo André | São Paulo | 09080-000 | Brazil |
| Praxis Pesquisa Médica | Santo André | São Paulo | 09090-790 | Brazil |
| Hospital Estadual Mario Covas | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital Sírio-Libanês | São Paulo | São Paulo | 01308-050 | Brazil |
| Universidade Federal de Sao Paulo - UNIFES | São Paulo | São Paulo | 04026-000 | Brazil |
| Hospital do Servidor Público Estadual/HSPE-SP | São Paulo | São Paulo | 04039-901 | Brazil |
| "City Clinic UMHAC" EOOD | Sofia | 1407 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | 1431 | Bulgaria |
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology | Edmonton | Alberta | T6G 2X8 | Canada |
| (G.I.R.I.) GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Winnipeg Regional Health Authority; Neurosurgery Department | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences Centre; Gastroenterology Research | Halifax | Nova Scotia | B3H 1V7 | Canada |
| University Hospital - London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Taunton Health Centre | Oshawa | Ontario | L1H 7K4 | Canada |
| The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit | Ottawa | Ontario | K1H 1A2 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Toronto Digestive Disease Associates | Vaughan | Ontario | L4L 4Y7 | Canada |
| Hôpital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| General Hospital Pula | Pula | 52100 | Croatia |
| Clinical Hospital Center Sestre Milosrdnice | Zagreb | 10000 | Croatia |
| Vojenska nemocnice Brno | Brno | 636 00 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika | Brno | 65691 | Czechia |
| Nemocnice Ceske Budejovice a.s. | České Budějovice | 370 01 | Czechia |
| Gastroenterologie s.r.o. | Hradec Králové | 500 02 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | 500 12 | Czechia |
| PreventaMed, s.r.o. | Olomouc | 779 00 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava - Poruba | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| ISCARE a.s. | Prague | 170 04 | Czechia |
| 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 |
| Hôpital Beaujon | Clichy | 92110 | France |
| Hopital Claude Huriez - CHU Lille | Lille | 59037 | France |
| CHU NANTES - Hôtel Dieu; Pharmacy | Nantes | 44093 | France |
| CHU Nice - Hopital de l'Archet 2 | Nice | 06202 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie | Pierre-Bénite | 69495 | France |
| CHU du Reims - Hopital Robert Debré | Reims | 51100 | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| Höpital Hautepierre; Pediatrie1 | Strasbourg | 67098 | France |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | 54511 | France |
| Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie | Berlin | 13353 | Germany |
| Krankenhaus Waldfriede e. V. | Berlin | 14163 | Germany |
| Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH | Bochum | 44789 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | 60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum Mannheim GmbH Universitätsklinikum | Mannheim | 68167 | Germany |
| Gemeinschaftspraxis | Schweinfurt | 97421 | Germany |
| Universitaetsklinikum Ulm | Ulm | 89081 | Germany |
| Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza | Békéscsaba | 5600 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika | Budapest | 1088 | Hungary |
| Szt Janos Korhaz es EbudaiEgyesitettKorhazak | Budapest | 1125 | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | 1136 | Hungary |
| Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika | Debrecen | 4012 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Haemek Medical Center | Afula | 18101 | Israel |
| Soroka University Medical Centre | Beersheba | 8410101 | Israel |
| Wolfson Medical Center | Holon | 5822012 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Holy Family Hospital | Nazareth | 1641101 | Israel |
| Rabin Medical Center-Beilinson Campus | Petah Tikva | 4941492 | Israel |
| Tel Aviv Sourasky Medical Center; Pharmacy | Tel Aviv | 6423906 | Israel |
| A.O.U. Policlinico di Modena | Modena | Emilia-Romagna | 40124 | Italy |
| Policlinico Universitario Agostino Gemelli; Farmacia | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 151 | Italy |
| Asst Fatebenefratelli Sacco (Fatebenefratelli) | Milan | Lombardy | 20121 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI) | Lombardy | 20097 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| Pauls Stradins Clinical University Hospital | R?ga | LV-1002 | Latvia |
| Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy | Riga | LV-1005 | Latvia |
| Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas | 50009 | Lithuania |
| Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology | Vilnius | 08661 | Lithuania |
| Clinical Research Institute | Tlalnepantla | Mexico CITY (federal District) | 54055 | Mexico |
| Medical Care & Research SA de CV | Mérida | Yucatán | 97000 | Mexico |
| Amsterdam UMC, Locatie VUMC; Gastroenterology | Amsterdam | 1081 HV | Netherlands |
| Amsterdam UMC Location AMC | Amsterdam | 1105 AZ | Netherlands |
| Leids Universitair Medisch Centrum; Cardiology | Leiden | 2333 ZA | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3000 CA | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| ETZ TweeSteden | Tilburg | 5042AD | Netherlands |
| North Shore Hospital | Auckland | 0620 | New Zealand |
| Christchurch Hospital NZ | Christchurch | 8011 | New Zealand |
| Dunedin Public Hospital | Dunedin | 9016 | New Zealand |
| Waikato Hospital | Hamilton | 3248 | New Zealand |
| Hutt Hospital | Lower Hutt | 5010 | New Zealand |
| Shakespeare Specialist Group | Takapuna | 0620 | New Zealand |
| Tauranga Hospital | Tauranga | 3143 | New Zealand |
| SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Bia?ystok | 15-275 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | 85-312 | Poland |
| Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ | Elblag | 82-300 | Poland |
| ETG Kielce | Kielce | 25-355 | Poland |
| Centrum Opieki Zdrowotnej Orkan-Med | Ksawerów | 95-054 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska | Lublin | 20-015 | Poland |
| Allmedica Badania Kliniczne Sp z o.o. Sp K. | Nowy Targ | 34-400 | Poland |
| Centrum Medyczne "MEDYK" | Rzeszów | 35-055 | Poland |
| Gabinet Lekarski, Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej SONOMED | Szczecin | 70-351 | Poland |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj | Toru? | 87-100 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-189 | Poland |
| Zespó Przychodni Specjalistycznych PRIMA | Warsaw | 02-018 | Poland |
| Przychodnia EuroMediCare | Wroc?aw | 50-220 | Poland |
| PlanetMed sp. z o.o. | Wroc?aw | 52-210 | Poland |
| LexMedica Osrodek Badan Klinicznych | Wroclaw | 53-114 | Poland |
| S.C MedLife S.A | Bucharest | 010719 | Romania |
| Spitalul Clinic Colentina | Sector 2 | 020125 | Romania |
| Centrul de Gastroenterologie Dr. Goldis | Timișoara | 300002 | Romania |
| LLC "Novosibirsk GastroCenter" | Novosibirsk | Altaj | 630007 | Russia |
| SBEI HPE Altai StateMedicalUniversityofMoH andSD | Barnaul | Altayskiy Kray | 656050 | Russia |
| LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology | Moscow | Moscow Oblast | 125015 | Russia |
| SEIHPE "Rostov SMU of MoH of RF" | Rostov-on-Don | Rostov Oblast | 344022 | Russia |
| Evromedservis LCC | Pushkin | Sankt-Peterburg | 196603 | Russia |
| Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department | Saint Petersburg | Sankt-Peterburg | 191015 | Russia |
| North-Western Medical University n.a. I.I. Mechnikov; Rheumatology | Saint Petersburg | Sankt-Peterburg | 191015 | Russia |
| Baltic Medicine | Saint Petersburg | Sankt-Peterburg | 194356 | Russia |
| SBIH City Clinical Hospital #31 | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| Irkutsk State Medical Academy of Continuing Education | Irkutsk | 664079 | Russia |
| SBEIHPE Novosibirsk State Medical University | Novosibirsk | 630091 | Russia |
| BHI of Omsk region Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| Clinical Center Zvezdara | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11040 | Serbia |
| General Hospital Djordje Joanovic | Zrenjanin | 23000 | Serbia |
| Endomed, s.r.o. | Košice | 040 01 | Slovakia |
| KM Management spol. s r.o. | Nitra | 94901 | Slovakia |
| Accout Center s.r.o. | Šahy | 936 01 | Slovakia |
| Dr D Epstein Practice | Cape Town | 7405 | South Africa |
| Emmed Research | Pretoria | 0002 | South Africa |
| Dong-A University Hospital | Busan | 49201 | 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 |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Clínic i Provincial; Servicio de Farmacia | Barcelona | 08036 | Spain |
| Hospital Reina Sofia; Medical Oncology | Córdoba | 14004 | Spain |
| Hospital Juan Ramón Jiménez | Huelva | 21005 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario de Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | 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 |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Hacettepe University Medical Faculty; Gastroenterology | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06500 | Turkey (Türkiye) |
| Acibadem Fulya Hospital; Neurology | Istanbul | 34349 | Turkey (Türkiye) |
| Haydarpasa Numune Training and Research Hospital; Gastroenterology | Istanbul | 34668 | Turkey (Türkiye) |
| Medeniyet University Goztepe Training and Research Hospital. | Kadiköy | 34722 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi; Infectious Diseases | Kocaeli | 41380 | Turkey (Türkiye) |
| Acibadem Kozyatagi Hospital; Gastroenterology | Kozyata?i | 34742 | Turkey (Türkiye) |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | Kharkiv Governorate | 61037 | Ukraine |
| CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine | Kharkiv | Kharkiv Governorate | 61204 | Ukraine |
| LLC Gastroenterology Center IBD Team | Zaporizhzhia | Kharkiv Governorate | 69000 | 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 |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | Kuban People's Republica | 76000 | Ukraine |
| RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU | Chernivtsi | 58002 | Ukraine |
| CHI Kharkiv City Clinical Hospital #13 | Kharkiv | 61124 | Ukraine |
| Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2 | Odesa | 65059 | 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 MC LLC Health Clinic | Vinnytsia | 21029 | Ukraine |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | EX2 5DW | United Kingdom |
| Queen Elizabeth Hospital | Kings Lynn | PE30 4ET | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Whipps Cross Hospital | London | E11 1NR | United Kingdom |
| University College London Hospital | London | N7 9NH | United Kingdom |
| Fairfield General Hospital | Manchester | M8 5RB | United Kingdom |
| Royal Victoria Infirmary; Stroke unit | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Nottingham University Hospitals Queen's Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
Participants received etrolizumab 105 mg, SC, Q4W for maximum of 320 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 study GA29144 who completed the 12-week safety follow-up period and were not eligible/did not wish to enroll in the Part 1 (OLE), enrolled directly in Part 2 (PML SM). Participant 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 a maximum of 320 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 320 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 study GA29144 who completed the 12-week safety follow-up period and were not eligible/did not wish to enroll in the Part 1 (OLE), enrolled directly in Part 2 (PML SM). Participant 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals | CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission. | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE |
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| Primary | Part 1: Number of Participants With Clinical Remission at 12-week Intervals | Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain (AP) mean daily score ≤1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces. | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Count of Participants | Participants | Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE |
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| Primary | Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 | SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as ≥50% reduction in SES-CD score compared to baseline. | OLE population included all participants who received at least one dose of study drug in Study GA29145 Part 1 (OLE). Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | At OLE Week 108 |
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| Primary | Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as 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 a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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 AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once. | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years) |
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| 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 popuation included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| Primary | Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 | AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AEs were graded 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. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade. | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| Primary | Part 1: Incidence Rate of Infection-related Adverse Event | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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. AE rate (per 100 participant years) = [Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable). | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Number | 95% Confidence Interval | event per 100 participant-years | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 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 popuation included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| 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 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 study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years) |
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| Primary | Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a 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 discontinued etrolizumab treatment during the OLE period have been reported here. | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 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 study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| Primary | Part 1: Incidence Rate of Malignancies | Malignancy rate (per 100 participant years) = [Total number of malignancies (in OLE only) / Total number of participant years at risk (in OLE only)]*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable). | OLE population included all participants who received at least one dose of study drug in study GA29145 Part 1 (OLE). | Posted | Number | 95% Confidence Interval | events per 100-participant-years | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| Primary | Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 | Hypersensitivity was reported using the MedDRA anaphylactic reaction standard MedDRA query (SMQ) and Sampson's criteria. 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 study drug in study GA29145 Part 1 (OLE). | Posted | Count of Participants | Participants | From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) |
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| Primary | Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML) | PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation). | PML SM population included all participants who entered the PML SM phase. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent study have been reported together. | Posted | Count of Participants | Participants | From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks |
|
|
Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or in study GA29144 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 Part 2 (PML SM) from Part 1 (OLE) or from the parent study GA29144. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent study 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 a maximum of 320 weeks followed by a 12-week safety follow-up. | 3 | 751 | 206 | 751 | 453 | 751 |
| EG001 | Part 2 (PML SM) | Participants from Part 1 (OLE) and from the study GA29144 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 Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered. | 1 | 359 | 1 | 359 | 2 | 359 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Noninfective gingivitis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Granulomatous liver disease | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Varicella meningitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Lisfranc fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Pregnancy test negative | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Cerebral haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vertebral artery stenosis | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 25.0 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Varicocele | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Paranasal sinus inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Septal panniculitis | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Colectomy | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Hernia repair | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Intestinal resection | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Neurosurgery | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Parenteral nutrition | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Peripheral revascularisation | Surgical and medical procedures | MedDRA version 25.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | 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 | Oct 8, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System 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 |
|
| Other |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Multiple |
|
| Unknown |
|
| Other |
|
|
| 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 |
|
|
| Units | Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|