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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003302-40 | EudraCT Number |
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Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.
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This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Active Comparator | Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first) |
|
| Placebo | Experimental | Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-Assessed Event-Free Survival (INV-assessed EFS) | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression [per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method. | Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. OS was estimated using the Kaplan-Meier method. | Randomization to death from any cause (up to 5 years, 5 months) |
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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 |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| University of California San Diego Medical Center; Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40079944 | Derived | Haddad R, Fayette J, Teixeira M, Prabhash K, Mesia R, Kawecki A, Dechaphunkul A, Dinis J, Guo Y, Masuda M, Hsieh CY, Ghi MG, Vaz de Melo Sette C, Harrington K, Tahara M, Saba NF, Lau A, Jiang T, Yan Y, Ballinger M, Kaul M, Matheny C, Cuchelkar V, Wong DJ. Atezolizumab in High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1599-1607. doi: 10.1001/jama.2025.1483. |
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A total of 406 participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN) were randomized in 1:1 ratio to receive either atezolizumab or placebo.
Participants took part in the study across 128 investigative sites in 23 countries from 03 April 2018 to 06 March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received atezolizumab matching placebo, intravenous (IV) infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
| FG001 |
| 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 | Feb 24, 2023 | Sep 16, 2024 |
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| Placebo | Drug | Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles. |
|
| Independent Review Facility (IRF) Assessed EFS |
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method. |
| Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years) |
| Percentage of Participants Event-Free for IRF-assessed EFS at 1, 2, 3, and 4 Years | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 & 4 years. | From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years |
| Percentage of Participants Event-Free for INV-assessed EFS at 1, 2, 3, and 4 Years | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by the investigator, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 & 4 years. | From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years |
| Percentage of Participants Event-Free for OS at 2, 3, and 5 Years | OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at 2, 3 and 5 years. | From randomization to OS event or date last known to be alive at 2, 3, and 5 Years |
| Change From Baseline in Physical Function (PF) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC-QLQ-C30) Score | EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptoms (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in PF was assessed using the PF scale, where participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) was scored on a 4-point scale (1=Not at All to 4=Very Much). Scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. | Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years) |
| Change From Baseline in Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 Score | EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome. | Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years) |
| Number of Participants With at Least One Adverse Event (AE) | An AE is untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. | From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months) |
| Serum Concentration of Atezolizumab | Predose and 0.5 hours post dose on Cycle 1 Day 1; Predose on Day 1 of Cycles 2, 4, 8, and 16 (Cycle length=21 days); study discontinuation visit (up to 1 year) |
| Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab | Number of participants positive for Treatment Emergent ADA is the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. | Predose on Day 1 of Cycles 1, 2, 4, 8 and 16 (Cycle length=21 days) |
| La Jolla |
| California |
| 92093 |
| United States |
| UCLA Hematology/Oncology | Santa Monica | California | 90404 | United States |
| Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Woodlands Medical Specialists, P.A. | Pensacola | Florida | 32503 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30329 | United States |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia | 30060 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Billings Clinic Research Center | Billings | Montana | 59101 | United States |
| Cleveland Clinic; Taussig Cancer Institute | Cleveland | Ohio | 44195 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Adelaide Cancer Centre | Kurralta Park | South Australia | 5037 | Australia |
| Peter MacCallum Cancer Center | North Melbourne | Victoria | 3051 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Santa Casa de Misericordia de Salvador | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Hospital do Cancer de Pernambuco - HCP | Recife | Pernambuco | 50040-000 | Brazil |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 90040-373 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Faculdade de Medicina do ABC - FMABC | Santo André | São Paulo | 09060-650 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Cancer Care Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200011 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Shanghai East Hospital | Shanghai | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430023 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Institut Sainte Catherine | Avignon | 84082 | France |
| Centre Georges Francois Leclerc | Dijon | 21000 | France |
| CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie | Lyon | 69373 | France |
| Hopital Timone Adultes; Oncologie Medicale Et Usp | Marseille | 13385 | France |
| ICM; Radiotherapie | Montpellier | 34298 | France |
| Hopital Tenon; Oncologie Radiotherapie | Paris | 75970 | France |
| CHU Bordeaux | Pessac | 33604 | France |
| Hôpitaux D'Instruction Des Armees Begin | Saint-Mandé | 94160 | France |
| Gustave Roussy Cancer Campus; Radiotherapie | Villejuif | 94805 | France |
| Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie | Bonn | 53127 | Germany |
| Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde | Freiburg im Breisgau | 79106 | Germany |
| Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko | München | 81377 | Germany |
| Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie | Rostock | 18059 | Germany |
| Orszagos Onkologial Intezet; Onkologiai Osztaly X | Budapest | 1122 | Hungary |
| Budapesti Uzsoki Utcai Kórház | Budapest | 1145 | Hungary |
| Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | 7623 | Hungary |
| Medanta-The Medicity | Gurgaon | Haryana | 122001 | India |
| Tata Memorial Hospital; Dept of Medical Oncology | Mumbai | Maharashtra | 400012 | India |
| Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma | Naples | Campania | 80131 | Italy |
| Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo | Lugo | Emilia-Romagna | 48022 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche | Rome | Lazio | 00161 | Italy |
| Ospedale Civile; Servizio Oncologia | Savona | Liguria | 17100 | Italy |
| Spedali Civili di Brescia | Brescia | Lombardy | 25123 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo | Milan | Lombardy | 20133 | Italy |
| Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica | Milan | Lombardy | 20142 | Italy |
| Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardy | 20089 | Italy |
| Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia | Florence | Tuscany | 50134 | Italy |
| IOV - Istituto Oncologico Veneto IRCCS | Padova | Veneto | 35128 | Italy |
| Aichi Cancer Center Hospital | Aichi | 464-8681 | Japan |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Hyōgo | 650-0017 | Japan |
| Miyagi Cancer Center | Miyagi | 981-1293 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Jikei University Hospital | Tokyo | 105-8471 | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo | 113-8519 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter. | Gliwice | 44-101 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi | Warsaw | 02-781 | Poland |
| IPO de Coimbra; Servico de Oncologia Medica | Coimbra | 3000-075 | Portugal |
| Hospital de Santa Maria; Servico de Oncologia Medica | Lisbon | 1649-035 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Krasnoyarsk | Krasnodarskiy Kray | 660133 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Main Military Clinical Hospital named after N.N. Burdenko | Moscow | Moscow Oblast | 105229 | Russia |
| P.A. Herzen Oncological Inst. ; Oncology | Moscow | Moscow Oblast | 125248 | Russia |
| First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery | Moskva | Moscow Oblast | 119435 | Russia |
| FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy. | Moskva | Moscow Oblast | 125367 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Sverdlovsk Regional Oncology Dispensary; Chemotherapy | Yekaterinburg | Sverdlovsk Oblast | 620905 | Russia |
| Novosibirsk Regional Oncological Dispancer | Novosibirsk | 630108 | Russia |
| BHI of Omsk region Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological | Tomsk | 634028 | Russia |
| Tygerberg Hospital; Oncology Dept | Cape Town | 7530 | South Africa |
| GVI Oncology Outeniqua Unit | George | 6530 | South Africa |
| The Oncology Centre; Haematology - Radiation Oncology | Mayville | 4001 | South Africa |
| Steve Biko Academic Hospital; Oncology | Pretoria | 0002 | South Africa |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | 08916 | Spain |
| Insititut Catala D'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28009 | Spain |
| Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | 37007 | Spain |
| Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia | Seville | 41014 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H | Taichung | 404 | Taiwan |
| Taichung Veterans General Hospital; Radiation Oncology | Taichung | Taiwan |
| National Cheng Kung University Hospital; Oncology | Tainan | 00704 | Taiwan |
| Division of Hematology and Oncology, Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| National Taiwan University Hospital; Oncology | Zhongzheng Dist. | 10048 | Taiwan |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital; Department of Oncology | Songkhla | 90110 | Thailand |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic | Ankara | 06200 | Turkey (Türkiye) |
| Gazi University Medical Faculty, Oncology Hospital | Ankara | 06500 | Turkey (Türkiye) |
| ?zmir Medical Point; Oncology | Kar?iyaka | 35575 | Turkey (Türkiye) |
| Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| Vinnytsya Regional Clinical Oncology Dispensary | Vinnytsia | Podolia Governorate | 21029 | Ukraine |
| Ivano-Frankivsk Regional Oncology Center | Ivano-Frankivsk | 76018 | Ukraine |
| Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients | Kiev | 03115 | Ukraine |
| ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department | Kryvyi Rih | 50048 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy | Lviv | 79031 | Ukraine |
| RCI Sumy Regional Clinical Oncological Dispensary | Sumy | 40005 | Ukraine |
| Aberdeen Royal Infirmary; Medical Oncology Dept | Aberdeen | AB25 2ZN | United Kingdom |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| The Royal Marsden Hospital, Fulham | London | SW3 6JJ | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8BT | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| Atezolizumab |
Participants received atezolizumab 1200 milligrams (mg), IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
| Received at Least One Dose of Study Drug | Safety-Evaluable Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all randomized participants, regardless of whether they received any of the assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received atezolizumab matching placebo, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
| BG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Human papilloma virus (HPV) Status | Count of Participants | Participants |
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| Type of Definitive Local Therapy | Count of Participants | Participants |
| ||||||||||||||||
| Response to Definitive Local Therapy | Responses were assessed according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Investigator-Assessed Event-Free Survival (INV-assessed EFS) | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression [per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. OS was estimated using the Kaplan-Meier method. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Randomization to death from any cause (up to 5 years, 5 months) |
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| Secondary | Independent Review Facility (IRF) Assessed EFS | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years) |
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| Secondary | Percentage of Participants Event-Free for IRF-assessed EFS at 1, 2, 3, and 4 Years | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 & 4 years. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an EFS event at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years |
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| Secondary | Percentage of Participants Event-Free for INV-assessed EFS at 1, 2, 3, and 4 Years | EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by the investigator, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 & 4 years. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an EFS event at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years |
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| Secondary | Percentage of Participants Event-Free for OS at 2, 3, and 5 Years | OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at 2, 3 and 5 years. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. Number analyzed per timepoint are unique number of participants out of all the assessed participants who remain at risk for an OS event at that timepoint. Different participants may have contributed data for each timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to OS event or date last known to be alive at 2, 3, and 5 Years |
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| Secondary | Change From Baseline in Physical Function (PF) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC-QLQ-C30) Score | EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptoms (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in PF was assessed using the PF scale, where participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) was scored on a 4-point scale (1=Not at All to 4=Very Much). Scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years) |
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| Secondary | Change From Baseline in Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 Score | EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome. | ITT population included all randomized participants, regardless of whether they received any of the assigned treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years) |
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| Secondary | Number of Participants With at Least One Adverse Event (AE) | An AE is untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. | Safety evaluable population included all randomized participants who received any amount of the study treatment. | Posted | Count of Participants | Participants | From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months) |
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| Secondary | Serum Concentration of Atezolizumab | Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of atezolizumab and provided at least one PK sample that was evaluable. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. Different participants may have contributed data for each timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliters (ug/mL) | Predose and 0.5 hours post dose on Cycle 1 Day 1; Predose on Day 1 of Cycles 2, 4, 8, and 16 (Cycle length=21 days); study discontinuation visit (up to 1 year) |
|
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab | Number of participants positive for Treatment Emergent ADA is the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. | ADA evaluable population included all randomized participants who received at least one dose of atezolizumab and who had at least one post-baseline ADA result. | Posted | Count of Participants | Participants | Predose on Day 1 of Cycles 1, 2, 4, 8 and 16 (Cycle length=21 days) |
|
|
For adverse events (AEs): From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months); For all-cause mortality: from randomization through the end of post-treatment survival follow-up (up to 5 years, 5 months)
Safety-evaluable population included all randomized participants who received any amount of the study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received atezolizumab matching placebo, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. | 69 | 203 | 32 | 203 | 144 | 203 |
| EG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. | 70 | 202 | 32 | 202 | 155 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Salivary gland fistula | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Death | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Implant site pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pharyngolaryngeal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Osteoradionecrosis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Postoperative adhesion | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Prerenal failure | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pharyngeal necrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Fistula repair | Surgical and medical procedures | MedDRA version 26.1 | Systematic Assessment |
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| Gastrostomy | Surgical and medical procedures | MedDRA version 26.1 | Systematic Assessment |
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| Medical device removal | Surgical and medical procedures | MedDRA version 26.1 | Systematic Assessment |
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| Muscle flap operation | Surgical and medical procedures | MedDRA version 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2022 | Sep 16, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Positive |
|
| No Primary Surgery |
|
| Partial Response (PR) or Stable Disease (SD) |
|
| Participants |
|
|
|
|
|
|
| OG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
|
|
|
| OG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
|
|
|
|
|
|
| OG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
|
|
| OG001 | Atezolizumab | Participants received atezolizumab 1200 mg, IV infusion on Day 1 of each 21-day cycle for 16 cycles or up to 1 year or until disease recurrence, disease progression, unacceptable toxicity, consent withdrawal, or study termination by sponsor, whichever occurred first. |
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| Units | Counts |
|---|---|
| Participants |
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