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| ID | Type | Description | Link |
|---|---|---|---|
| IMvigor 210 | Other Identifier | Genentech Inc. | |
| 2013-005486-39 | EudraCT Number |
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This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1 are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 2: Participants With Second-line or Beyond Treatments | Experimental | Participants with advanced disease who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1200 mg given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria/loss of clinical benefit or unmanageable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. |
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Inclusion Criteria:
Cohort 2-Specific 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 |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Pinnacle Oncology Hematology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410325 | Derived | Holm JS, Funt SA, Borch A, Munk KK, Bjerregaard AM, Reading JL, Maher C, Regazzi A, Wong P, Al-Ahmadie H, Iyer G, Tamhane T, Bentzen AK, Herschend NO, De Wolf S, Snyder A, Merghoub T, Wolchok JD, Nielsen M, Rosenberg JE, Bajorin DF, Hadrup SR. Neoantigen-specific CD8 T cell responses in the peripheral blood following PD-L1 blockade might predict therapy outcome in metastatic urothelial carcinoma. Nat Commun. 2022 Apr 11;13(1):1935. doi: 10.1038/s41467-022-29342-0. | |
| 33241650 |
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The analysis included data up to cutoff date 28 February 2023.
The study is considered "Completed" because the planned study activities and analyses have been performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 2: Participants With Second-line or Beyond Treatments | Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| DOR as Assessed by the Investigator According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| DOR as Assessed by the Investigator According to Modified RECIST | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| PFS as Assessed by the Investigator According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| PFS as Assessed by the Investigator According to Modified RECIST | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants Who Died | The percentage of participants who died from any cause was reported. | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Overall Survival (OS) | OS was defined as the time from start of treatment to the time of death from any cause on study. | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Percentage of Participants Alive at 1-year | 1-year |
| Maximum Serum Concentration (Cmax) of Atezolizumab | Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) |
| Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) |
| Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Arizona Oncology - HOPE Wilmot | Tucson | Arizona | 85710 | United States |
| UCLA | Los Angeles | California | 90024 | United States |
| The Angeles Clinic and Research Institute - W LA Office | Los Angeles | California | 90025 | United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| UCSF | San Francisco | California | 94143-0106 | United States |
| Kaiser Permanente - San Marcos | San Marcos | California | 92069 | United States |
| Stanford Cancer Center | Stanford | California | 94305-5820 | United States |
| Kaiser Permanente; Oncology Clinical Trials | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Center - Aurora | Aurora | Colorado | 80012 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Yale Cancer Center ; Medical Oncology | New Haven | Connecticut | 06520 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | United States |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | United States |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | United States |
| University of Chicago; Hematology/Oncology | Chicago | Illinois | 60637 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Indiana University Health; Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40402 | United States |
| Massachusetts General Hospital;Oncology | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Inst. ; Dept. of Medical Oncology | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine | Boston | Massachusetts | 02215 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Minnesota Oncology Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12208 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Mount Sinai School of Medicine - Tisch Cancer Institute | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Case Western Reserve Univ; Hem/Onc | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon | 97401-8122 | United States |
| Kimmel Cancer Center Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | United States |
| Ctr for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Texas Oncology - Houston (Gessner) | Houston | Texas | 77024 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates - Lake Wright Cancer Center | Norfolk | Virginia | 23502 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Bcca - Cancer Center Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | H3T 1E2 | Canada |
| APHP - Hospital Saint Louis | Paris | 75475 | France |
| Hopital Foch; Oncologie | Suresnes | 92151 | France |
| Institut Gustave Roussy; Oncologie Medicale | Villejuif | 94800 | France |
| Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie | Berlin | 12200 | Germany |
| Universitätsklinikum Düsseldorf; Urologische Klinik | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II | Hamburg | 20246 | Germany |
| Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik | München | 81675 | Germany |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milan | Lombardy | 20133 | Italy |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Arezzo | Tuscany | 52100 | Italy |
| The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Barts and The London | London | EC1M 6BQ | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | L63 4JY | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. |
| 29489427 | Derived | Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28. |
| 29273410 | Derived | Perez-Gracia JL, Loriot Y, Rosenberg JE, Powles T, Necchi A, Hussain SA, Morales-Barrera R, Retz MM, Niegisch G, Duran I, Theodore C, Grande E, Shen X, Wang J, Nelson B, Derleth CL, van der Heijden MS. Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens. Eur Urol. 2018 Mar;73(3):462-468. doi: 10.1016/j.eururo.2017.11.023. Epub 2017 Dec 20. |
| 28950298 | Derived | Necchi A, Joseph RW, Loriot Y, Hoffman-Censits J, Perez-Gracia JL, Petrylak DP, Derleth CL, Tayama D, Zhu Q, Ding B, Kaiser C, Rosenberg JE. Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study. Ann Oncol. 2017 Dec 1;28(12):3044-3050. doi: 10.1093/annonc/mdx518. |
| 28552987 | Derived | Snyder A, Nathanson T, Funt SA, Ahuja A, Buros Novik J, Hellmann MD, Chang E, Aksoy BA, Al-Ahmadie H, Yusko E, Vignali M, Benzeno S, Boyd M, Moran M, Iyer G, Robins HS, Mardis ER, Merghoub T, Hammerbacher J, Rosenberg JE, Bajorin DF. Contribution of systemic and somatic factors to clinical response and resistance to PD-L1 blockade in urothelial cancer: An exploratory multi-omic analysis. PLoS Med. 2017 May 26;14(5):e1002309. doi: 10.1371/journal.pmed.1002309. eCollection 2017 May. |
| 27939400 | Derived | Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. |
| 26952546 | Derived | Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Cohort 2 Safety Evaluable Population included all participants who received any amount of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 2: Participants With Second-line or Beyond Treatments | Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity. |
| 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 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. | Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
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| Primary | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Cohort 2 objective response-evaluable population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
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| Secondary | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Median | Full Range | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| |||||||||||||||||||||||||||
| Secondary | DOR as Assessed by the Investigator According to RECIST v1.1 | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Median | Full Range | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
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| Secondary | DOR as Assessed by the Investigator According to Modified RECIST | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. | Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Median | Full Range | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Cohort 2 ITT population | Posted | Number | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Cohort 2 ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Cohort 2 ITT population | Posted | Number | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| |||||||||||||||||||||||||||
| Secondary | PFS as Assessed by the Investigator According to RECIST v1.1 | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Cohort 2 ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST | Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. | Cohort 2 ITT population | Posted | Number | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| |||||||||||||||||||||||||||
| Secondary | PFS as Assessed by the Investigator According to Modified RECIST | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Cohort 2 ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. | Cohort 2 objective response-evaluable population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died | The percentage of participants who died from any cause was reported. | Cohort 2 ITT population | Posted | Number | percentage of participants | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
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| Secondary | Overall Survival (OS) | OS was defined as the time from start of treatment to the time of death from any cause on study. | Cohort 2 ITT population | Posted | Median | 95% Confidence Interval | months | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive at 1-year | Cohort 2 ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | 1-year |
|
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| Secondary | Maximum Serum Concentration (Cmax) of Atezolizumab | Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome. | Posted | Mean | Standard Deviation | microgram(s)/milliliter (mcg/mL) | Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Minimum Serum Concentration (Cmin) of Atezolizumab | Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available. | Posted | Number | percentage of participants | Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months) |
|
|
First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months)
All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
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 | MPDL3280A COHORT2 INFUSION | 253 | 310 | 155 | 310 | 287 | 310 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LYMPH NODE PAIN | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ANAL INCONTINENCE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| AUTOIMMUNE COLITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMORRHAGIC CYST | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BILIARY SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| BURSITIS INFECTIVE STAPHYLOCOCCAL | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| CELLULITIS OF MALE EXTERNAL GENITAL ORGAN | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| MENINGOENCEPHALITIS HERPETIC | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| RETROPERITONEAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION PSEUDOMONAL | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ILIUM FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| STOMA SITE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM RUPTURED | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| TUMOUR ASSOCIATED FEVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIPLEGIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PARAPLEGIA | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| THROMBOSIS IN DEVICE | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BLADDER PERFORATION | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYDROURETER | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PENILE PAIN | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PULMONARY ARTERY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| IMMOBILE | Social circumstances | MedDRA 26.0 | Systematic Assessment |
| |
| RENAL STONE REMOVAL | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| URETERAL STENT INSERTION | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 26.0 | 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 |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
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