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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005603-25 | EudraCT Number |
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Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.
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This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). |
|
| Observation | No Intervention | Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered at a dose of 1200 milligrams (mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS), as Assessed by Investigator | DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. | Randomization up to first occurrence of DFS event (up to approximately 50 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation. | Randomization until death due to any cause (up to approximately 80 months) |
| Disease-Specific Survival (DSS), as Assessed by Investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network | Scottsdale | Arizona | 85258 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41720562 | Derived | Landon BV, Huang J, Evangelopoulou EG, Anagnostou V, Canzoniero JV. Liquid biopsy approaches to capture minimal residual disease and therapy response in patients with early stage cancers. Int Rev Cell Mol Biol. 2026;399:113-143. doi: 10.1016/bs.ircmb.2024.12.002. Epub 2024 Dec 14. | |
| 41144872 | Derived | Elias R, Aragaki AK, Hoffman-Censits JH, Hahn NM, McConkey DJ, Johnson BA 3rd. Intratumoral Expression of a Composite B Cell / CD8 T Cell Biomarker Stratifies Overall Survival by Circulating Tumor DNA Status and Benefit From Adjuvant Immunotherapy in High-Risk Muscle-Invasive Urothelial Carcinoma. J Urol. 2026 Mar;215(3):294-304. doi: 10.1097/JU.0000000000004828. Epub 2025 Oct 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observation | Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). |
| FG001 | Atezolizumab | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 13, 2020 | Oct 21, 2020 |
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DSS is defined as the time from randomization until the date of death from UC. |
| Randomization until death due to UC (up to approximately 50 months) |
| Distant Metastasis-Free Survival (DMFS) | DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations. | Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) |
| Non-Urinary Tract Recurrence-Free Survival (NURFS) | NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. | Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) |
| Percentage of Participants With Adverse Events (AEs) | Percentage of participants with at least one Adverse Event. | Screening up to approximately 80 months |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Percentage of participants with anti-therapeutic antibodies to atezolizumab. | Baseline up to approximately 50 months |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score | The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state." | Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab. | Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days) |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1. | Day 1 of Cycle 1 (Cycle length = 21 days) |
| UCLA |
| Los Angeles |
| California |
| 90024 |
| United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Yale Cancer Center; Medical Oncology | New Haven | Connecticut | 06520 | United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago; Hematology/Oncology | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospital & Clinic; Division of Hematology/Oncology | Iowa City | Iowa | 52242 | United States |
| Albert B. Chandler Medical Center; University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 2114 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| MSK @Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Saint Barnabas Medical Center Cancer Center | Livingston | New Jersey | 07039 | United States |
| Memorial Sloan-Kettering Cancer Center | Commack | New York | 11725 | United States |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| Fairview Hospital; Cleveland Clinic Cancer Center | Cleveland | Ohio | 44111 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Cleveland CL N Coast Cancer Cr | Sandusky | Ohio | 44870 | United States |
| Abramson Cancer Center; Univ of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase-Temple Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390-8897 | United States |
| Baylor College of Medicine; Gastroenterology | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22906 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2109 | Australia |
| Royal Brisbane & Women's Hosp; Cancer Care Serv | Herston | Queensland | 4029 | Australia |
| Monash Medical Centre; Oncology | Clayton | Victoria | 3168 | Australia |
| Austin and Repatriation Medical Centre; Cancer Services | Melbourne | Victoria | 3084 | Australia |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta | T6G 1Z2 | Canada |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario | K1H 8L6 | Canada |
| North York General Hospital | Toronto | Ontario | M2J 1V1 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University; Glen Site; Oncology | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Quebec Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Peking University First Hospital | Beijing | 100034 | China |
| Friendship Hospital, Capital Medical University | Beijing | 100050 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The Second Affiliated Hospital, Sun Yat-sen University | Guangzhou | 510120 | China |
| Jiangsu Province Hospital | Nanjing | 210008 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | 200040 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200092 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Multiscan s.r.o. | Pardubice | 532 03 | Czechia |
| University Hospital Motol; Department of Urology | Prague | 15006 | Czechia |
| Helsinki University Central Hospital; Urology Clinics | Helsinki | 00029 | Finland |
| Tampere University Hospital; Dept Of Urology | Tampere | 33520 | Finland |
| Turku University Central Hospital; Urology clinic | Turku | 20520 | Finland |
| ICO Paul Papin; Oncologie Medicale. | Angers | 49055 | France |
| Institut Sainte Catherine;Recherche Clinique | Avignon | 84918 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Centre Francois Baclesse; Recherche Clinique | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital Cochin; Unite Fonctionnelle D Oncologie | Paris | 75014 | France |
| Hopital Saint Louis; Oncologie Medicale | Paris | 75475 | France |
| Institut Mutualiste Montsouris; Oncologie | Paris | 75674 | France |
| Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale | Paris | 75908 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie | Berlin | 10117 | Germany |
| Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin | Bochum | 44791 | Germany |
| Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf; Urologische Klinik | Düsseldorf | 40225 | Germany |
| Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik | Herne | 44625 | Germany |
| Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie | Mannheim | 68167 | Germany |
| Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik | München | 81675 | Germany |
| Universitätsmedizin Rostock, Urologische Klinik und Poliklinik | Rostock | 18057 | Germany |
| Diakonie-Klinikum Stuttgart; Urologische Klinik | Stuttgart | 70176 | Germany |
| Universitätsklinikum Tübingen; Klinik für Urologie | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm; Klinik für Urologie | Ulm | 89081 | Germany |
| Alexandras General Hospital of Athens; Oncology Department | Athens | 115 28 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Rambam Health Care Campus; Oncology - Hafia | Hafia | 3109601 | Israel |
| Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | 9112000 | Israel |
| Meir Medical Center; Oncology | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center; Oncology Dept | Petah Tikva | 4910000 | Israel |
| Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | 5262100 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Assaf Harofeh; Oncology | Ẕerifin | 6093000 | Israel |
| Az. Osp. Cardarelli; Divisione Di Oncologia | Naples | Campania | 80131 | Italy |
| ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica | Rome | Lazio | 00152 | Italy |
| Irccs Ospedale San Raffaele;Oncologia Medica | Milan | Lombardy | 20132 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche | Milan | Lombardy | 20141 | Italy |
| A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica | Orbassano | Piedmont | 10043 | Italy |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Arezzo | Tuscany | 52100 | Italy |
| Azienda Ospedaliera S. Maria - Terni; Oncologia | Terni | Umbria | 05100 | Italy |
| Nagoya University Hospital; Urology | Aichi | 466-8560 | Japan |
| Hirosaki University School of Medicine & Hospital; Urology | Aomori | 036-8563 | Japan |
| Shikoku Cancer Center | Ehime | 791-0280 | Japan |
| Hiroshima City Hiroshima Citizens Hospital; Urology | Hiroshima | 730-8518 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| University of Tsukuba Hospital | Ibaraki | 305-8576 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Iwate Medical University Hospital; Urology | Numakunai | 028-3695 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka University Hospital; Urology | Osaka | 565-0871 | Japan |
| Kindai University Hospital; Urology | Osaka | 589-8511 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| Shizuoka Cancer Center; Urology | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital; Urology | Tokyo | 104-0045 | Japan |
| The University of Tokyo Hospital | Tokyo | 113-8655 | Japan |
| The Cancer Institute Hospital, JFCR; Urology | Tokyo | 135-8550 | Japan |
| Kyorin University Hospital | Tokyo | 181-8611 | Japan |
| NKI/AvL | Amsterdam | 1066 CX | Netherlands |
| VU MEDISCH CENTRUM; Dept. of Medical Oncology | Amsterdam | 1081 HV | Netherlands |
| Academ Ziekenhuis Groningen; Medical Oncology | Groningen | 9713 GZ | Netherlands |
| Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie | Rotterdam | 3015AA | Netherlands |
| St. Antonius locatie Leidsche Rijn | Utrecht | 3543 AZ | Netherlands |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii | Późna | 60-569 | Poland |
| SpecjalistycznySzpital Miejski w Toruniu; Oddzia? Urologii Ogólnej i Onkologicznej | Toru? | 87-100 | Poland |
| Szpital Kliniczny Dzieci?tka Jezus; Oddzia? Urologii | Warsaw | 02-005 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii | Wroclaw | 50-556 | Poland |
| SBEI of HPE ?Bashkir State Medical University? of MoH RF | Ufa | Bashkortostan Republic | 450000 | Russia |
| P.A. Herzen Oncological Inst. ; Oncology | Moscow | Moscow Oblast | 125248 | Russia |
| Privolzhsk Regional Medical Center | Nizhny Novgorod | Niznij Novgorod | 603001 | Russia |
| Sverdlovsk Regional Oncology Dispensary; Chemotherapy | Yekaterinburg | Sverdlovsk Oblast | 620905 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje" | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia; Clinic of Urology | Belgrade | 11000 | Serbia |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Sant Andreu de la Barca | Barcelona | 08740 | Spain |
| Hospital de Donostia; Servicio de Oncologia Medica | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zurich | 8091 | Switzerland |
| Taichung Veterans General Hospital; Division of Urology | Taichung | 407 | Taiwan |
| National Taiwan University Hospital, Department of Urology | Taipei | 10048 | Taiwan |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | 01230 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Medikal Park Izmir Hospital | Kar??yaka | 35575 | Turkey (Türkiye) |
| Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4 | Kharkiv | Kharkiv Governorate | 61037 | Ukraine |
| CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR | Dnipropetrovsk | 49102 | Ukraine |
| GU "Institution of urology of Academy Medical science of Ukraine" | Kiev | 04053 | Ukraine |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| University Hospitals Bristol NHS Foundation Trust | Bristol | BS2 8HW | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Barts Health NHS Trust - St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| James Cook Uni Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Preston Hosptial | Preston | PR2 9HT | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| 37601688 | Derived | Powles T, Young A, Nimeiri H, Madison RW, Fine A, Zollinger DR, Huang Y, Xu C, Gjoerup OV, Aushev VN, Wu HT, Aleshin A, Carter C, Davarpanah N, Degaonkar V, Gupta P, Mariathasan S, Schleifman E, Assaf ZJ, Oxnard G, Hegde PS. Molecular residual disease detection in resected, muscle-invasive urothelial cancer with a tissue-based comprehensive genomic profiling-informed personalized monitoring assay. Front Oncol. 2023 Jul 31;13:1221718. doi: 10.3389/fonc.2023.1221718. eCollection 2023. |
| 37500339 | Derived | Powles T, Assaf ZJ, Degaonkar V, Grivas P, Hussain M, Oudard S, Gschwend JE, Albers P, Castellano D, Nishiyama H, Daneshmand S, Sharma S, Sethi H, Aleshin A, Shi Y, Davarpanah N, Carter C, Bellmunt J, Mariathasan S. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma. Eur Urol. 2024 Feb;85(2):114-122. doi: 10.1016/j.eururo.2023.06.007. Epub 2023 Jul 26. |
| 33721560 | Derived | Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observation | Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). |
| BG001 | Atezolizumab | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Number of 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 | Disease-Free Survival (DFS), as Assessed by Investigator | DFS is defined as the time from randomization to the time of first occurrence of a DFS event. DFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); urinary tract recurrence of UC (including all pathological stages and grades); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Median | 95% Confidence Interval | Months | Randomization up to first occurrence of DFS event (up to approximately 50 months) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death from any cause, regardless of whether the death occurs during study treatment or following treatment discontinuation. | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Median | 95% Confidence Interval | Months | Randomization until death due to any cause (up to approximately 80 months) |
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| Secondary | Disease-Specific Survival (DSS), as Assessed by Investigator | DSS is defined as the time from randomization until the date of death from UC. | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Median | 95% Confidence Interval | Months | Randomization until death due to UC (up to approximately 50 months) |
|
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| Secondary | Distant Metastasis-Free Survival (DMFS) | DMFS is defined as the time from randomization to the date of diagnosis of distant (that is, non-locoregional) metastases or death from any cause. Tumor assessment will be performed using radiographic evaluations. | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Median | 95% Confidence Interval | Months | Randomization up to diagnosis of distant metastases or death from any cause (up to approximately 50 months) |
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| Secondary | Non-Urinary Tract Recurrence-Free Survival (NURFS) | NURFS is defined as the time from randomization to the time of first occurrence of a NURFS event. NURFS events include: local (pelvic) recurrence of UC (including soft tissue and regional lymph nodes); distant metastasis of UC; or death from any cause. Tumor assessment will be performed using radiographic evaluations. | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Median | 95% Confidence Interval | Months | Randomization up to time of first occurrence of a NURFS event (up to approximately 50 months) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | Percentage of participants with at least one Adverse Event. | The safety population is defined as patients who received at least one dose of atezolizumab, and all patients who did not receive any dose of atezolizumab who had at least one post-baseline safety assessment (e.g.,adverse event, lab, vital signs, ECG, etc.), regardless of their assigned treatment (atezolizumab/observation). | Posted | Number | Percentage of Participants | Screening up to approximately 80 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Percentage of participants with anti-therapeutic antibodies to atezolizumab. | The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result. | Posted | Number | Percentage of Participants | Baseline up to approximately 50 months |
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| Secondary | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score | The EQ-5D-5L is a generic preference-based HRQoL questionnaire that provides a single index value for health status and is used to inform pharmacoeconomic evaluations and to measure general health status. Visual analog scale (VAS) allows the patient to indicate, on a scale of 0-100, how his or her health is on the day of assessment, with 100 being the "best imaginable health state" and 0 being the "worst imaginable health state." | The ITT population is defined as all randomized patients, whether or not the patient received the assigned treatment (atezolizumab/observation). | Posted | Mean | Standard Deviation | Score on scale | Day 1 of Cycle 1 up to approximately 50 months (Cycle length = 21 days) |
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| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin) prior to infusion on Day 1 of Cycles 1, 2, 3, and 4; every 8 cycles starting on Cycle 8; at treatment discontinuation; and at 120 days after the last dose of atezolizumab. | The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples. | Posted | Mean | Standard Deviation | µg/mL | Pre-dose (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, every 8 cycles from Cycle 8, at treatment discontinuation, 120 days after treatment discontinuation (up to approximately 50 months))(Cycle length = 21 days) |
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| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax) after infusion on Day 1 of Cycle 1. | The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab and who have evaluable pharmacokinetic (PK) samples. | Posted | Mean | Standard Deviation | µg/mL | Day 1 of Cycle 1 (Cycle length = 21 days) |
|
|
From the first study drug to the data cutoff date: 14 June 2022 (up to 80 months)
Safety-evaluable population for atezolizumab included patients who received at least 1 dose of atezolizumab. Safety-evaluable population for observation included patients randomized to observation who had at least 1 post-baseline safety assessment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
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 | OBSERVATION | Participants underwent observation starting on Day 1 for 16 cycles (up to 1 year). | 162 | 403 | 72 | 398 | 234 | 398 |
| EG001 | ATEZOLIZUMAB | Participants received intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year). | 171 | 406 | 122 | 390 | 324 | 390 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine 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 |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | 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 |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Small intestine ulcer | 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 |
| |
| Death | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hernia pain | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Lithiasis | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hepatic haematoma | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Systemic immune activation | Immune system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Osteomyelitis | 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 |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Sinusitis | 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 |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Incision site impaired healing | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Ureteric anastomosis complication | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Urostomy complication | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Musculoskeletal pain | 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 |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Tumour of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 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 |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA version 25.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Autoimmune nephritis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Immune-mediated neurological disorder | Nervous system 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 |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Constipation | 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 |
| |
| Asthenia | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 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 |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 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 |
| |
| Myalgia | 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 |
| |
| Dizziness | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue 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 | Feb 1, 2019 | Oct 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Black or African American |
|
| White |
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| Other |
|
| Unknown |
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