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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003695-47 | EudraCT Number | ||
| BIG 16-05 | Other Identifier | Breast International Group (BIG) | |
| AFT-27 | Other Identifier | Alliance Foundation Trials | |
| ALEXANDRA | Other Identifier | Breast International Group (BIG) |
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The study was terminated by the sponsor following interim analysis as the primary endpoint of iDFS crossed the pre-specified futility boundary of hazard ratio > 1 in the Intent-to-Treat (ITT) population.
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| Name | Class |
|---|---|
| Breast International Group | OTHER |
| Alliance Foundation Trials, LLC. | OTHER |
| Jules Bordet Institute | OTHER |
| Frontier Science & Technology Research Foundation, Inc. |
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This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Chemotherapy | Experimental | Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) |
|
| Chemotherapy | Active Comparator | Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) | iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; & Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. |
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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 |
|---|---|---|---|---|---|---|
| John Muir Health Clinical Research Center | Concord | California | 94520 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39883436 | Derived | Ignatiadis M, Bailey A, McArthur H, El-Abed S, de Azambuja E, Metzger O, Chui SY, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger GG, Jassem J, Lee SC, Higgins M, Zarba J, Schmidt M, Gomez H, Guerrero Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch NE, Bajetta E, Ohno S, Im SA, Werutsky G, Gal-Yam EN, Gonzalez Farre X, Tseng LM, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron DA, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30;333(13):1150-60. doi: 10.1001/jama.2024.26886. Online ahead of print. | |
| 32450725 |
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A total of 2199 participants were enrolled in the study. Participants were randomized in a 1:1 ratio to receive Atezolizumab and Chemotherapy or Chemotherapy alone.
Participants with newly diagnosed Stage II-III primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery, were enrolled in 342 centers in 31 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy | Participants were administered paclitaxel, 80 milligram per square meter (mg/m^2), intravenous (IV) infusion weekly (QW) for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated every 2 weeks (Q2W) for a maximum of 20 weeks supported with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) treatment. |
| 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 | Mar 1, 2023 | Jul 29, 2024 |
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| INDUSTRY |
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| Paclitaxel | Drug | Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks. |
|
| Dose-dense Doxorubicin or dose-dense Epirubicin | Drug | Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses |
|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses |
|
| From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
| Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | From randomization up to death from any cause (up to 5 years) |
| Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | From randomization up to death from any cause (up to 5 years) |
| Recurrence-Free Interval (RFI) | Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional [including invasive ipsilateral tumor and invasive locoregional tumor], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored. | From randomization up to 5 years |
| Distant Recurrence-Free Interval (DRFI) | Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored. | From randomization up to 5 years |
| Disease-Free Survival (DFS) | Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | From randomization up to first disease recurrence or death from any cause (up to 5 years) |
| Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7]) | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement. | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
| Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5]) | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, 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) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning. | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
| Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
| Number of Participants With Adverse Events (AE) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. | Up to 5 years |
| Serum Concentration of Atezolizumab | Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample. | Up to 5 years |
| Los Angeles |
| California |
| 90048 |
| United States |
| Martin-O?Neil Cancer Center | St. Helena | California | 94574 | United States |
| Baptist - MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Advocate Illinois Masonic Outpatient Center for Advanced Care | Chicago | Illinois | 60657 | United States |
| Des Moines Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Fairview Southdale Medical Oncology Clinic | Edina | Minnesota | 55435 | United States |
| HCA Midwest Division | Kansas City | Missouri | 64132 | United States |
| New Hampshire Hematology Oncology | Manchester | New Hampshire | 03103 | United States |
| Monter Cancer Center | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 11101 | United States |
| Rochester General Hospital; Lipson Cancer and Blood Center | Rochester | New York | 14621 | United States |
| SCRI | Nashville | Tennessee | 37203 | United States |
| Intermountain Precision Genomics Cancer Research Clinic-Dixie | St. George | Utah | 84770 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| Centro de Oncologia e; Investigacion Buenos Aires - COIBA | Berazategui | B1880BBF | Argentina |
| INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology | Ciudad Autonoma Buenos Aires | C1012AAR | Argentina |
| Hospital Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | C1284AEB | Argentina |
| Clinica Universitaria Reina Fabiola | Córdoba | X5004FHP | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Instituto de Oncología de Rosario | Rosario | S2000KZE | Argentina |
| Centro Medico San Roque | San Miguel de Tucumán | T4000IAK | Argentina |
| Fundación Ars Medica | San Salvador de Jujuy | Argentina |
| Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department | Viedma | R8500ACE | Argentina |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Lismore Base Hospital | Lismore | New South Wales | 2480 | Australia |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2113 | Australia |
| Sydney Adventist Hospital | Wahroonga | New South Wales | 2076 | Australia |
| Icon Cancer Care Wesley | Auchenflower | Queensland | 4066 | Australia |
| Icon Cancer Foundation; Icon Cancer Care Chermside | Chermside | Queensland | 4032 | Australia |
| Icon Cancer Care South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Mater Hospital; Cancer Services | South Brisbane | Queensland | 4101 | Australia |
| Icon Cancer Foundation; Icon Cancer Care Southport | Southport | Queensland | 4215 | Australia |
| Princess Alexandra Hospital; Cancer Trials Unit | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital; Cancer Centre | Adelaide | South Australia | 5000 | Australia |
| Ashford Cancer Center Research | Kurralta Park | South Australia | 5037 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Austin Hospital Olivia Newton John Cancer Centre | Heidelberg | Victoria | 3084 | Australia |
| Maroondah Hospital; Breast Clinic | Ringwood East | Victoria | 3135 | Australia |
| Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn | Innsbruck | 6020 | Austria |
| Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie | Linz | 4010 | Austria |
| Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU | Salzburg | 5020 | Austria |
| AKH - Medizinische Universität Wien; Department of Oncology | Vienna | 1090 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Vienna | 1090 | Austria |
| Salzkammergut-Klinikum Voecklabruck | Vöcklabruck | 4840 | Austria |
| Klinikum Kreuzschwestern Wels; Iv. Interne Abt. | Wels | 4600 | Austria |
| AZ KLINA | Brasschaat | 2930 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHC MontLégia | Liège | 4000 | Belgium |
| Chr de La Citadelle | Liège | 4000 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| Clinique Sainte-Elisabeth; Oncologie | Namur | 5000 | Belgium |
| Vitaz | Sint-Niklaas | 9100 | Belgium |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-232 | Brazil |
| Nucleo de Oncologia da Bahia - NOB | Salvador, Bahia | Estado de Bahia | 40170-380 | Brazil |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Hospital Jardim Amália | Volta Redonda | Rio de Janeiro | 27251-260 | Brazil |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90110-000 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Faculdade de Medicina do ABC - FMABC | Santo André | São Paulo | 09060-650 | Brazil |
| Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira | São Paulo | São Paulo | 01246 000 | Brazil |
| Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia | São Paulo | São Paulo | 04014-002 | Brazil |
| Peking University People's Hospital | Beijing | 100044 | China |
| Beijing Hospital; Internal Medicine-Oncology | Beijing | 100730 | China |
| Beijing Union Hospital | Beijing | 100730 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Chongqing Cancer Hospital | Chongqing | 400030 | China |
| The 900th Hospital of PLA joint service support force | Fuzhou | 110016 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| Sun yat-sen University Cancer Center; Internal Medicine of Oncology | Guangzhou | 510060 | China |
| Guangdong General Hospital | Guangzhou | 510080 | China |
| Sun Yat-Sen University Cancer Center - Huangpu Campus | Guangzhou | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University College | Hangzhou | 310009 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Luoyang Central Hospital | Luoyang | 471000 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | 210008 | China |
| Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | 200025 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee | Shenzhen | 518053 | China |
| Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) | Shijiazhuang | 050035 | China |
| Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Xi'an | 710061 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Nemocnice Horovice, NH Hospital a.s.; Oncology Department | Hořovice | 26831 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Krajska nemocnice T. Bati, a.s. | Zlín | 76001 | Czechia |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed | Odense C | 5000 | Denmark |
| Sygehus Lillebælt, Vejle | Vejle | 7100 | Denmark |
| Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy | Ars-Laquenexy | 57530 | France |
| Institut Sainte Catherine | Avignon | 84082 | France |
| CH de Beauvais | Beauvais | 60000 | France |
| CHU Jean Minjoz | Besançon | 25030 | France |
| Clinique Tivoli; Sce Radiotherapie | Bordeaux | 33000 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| Centre Hospitalier Fleyriat | Bourg-en-Bresse | 01012 | France |
| CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie | Brest | 29609 | France |
| CRLCC-Francois Baclesse; Oncologie Médicale | Caen | 14076 | France |
| CH de Cholet; oncologie | Cholet | 49325 | France |
| Centre Hospitalier de Compiegne | Compiègne | 60321 | France |
| Centre Hospitalier Alpes Leman | Contamine-sur-Arve | 74130 | France |
| Centre Georges Francois Leclerc | Dijon | 21000 | France |
| Centre Hospitalier Departemental de Vendee | La Roche-sur-Yon | 85925 | France |
| Clinique Chenieux; Oncology | Limoges | 87039 | France |
| Centre Hospitalier Bretagne Sud | Lorient | 56100 | France |
| Hopital Prive Jean Mermoz | Lyon | 69008 | France |
| Hôpital Saint Joseph | Marseille | 13008 | France |
| Clinique Clémentville | Montpellier | 34070 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| l'Hôpital privé du Confluent SAS | Nantes | 44202 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| CH Annecy Genevois site Annecy; Oncologie | Pringy | 74374 | France |
| Chi De Cornouaille; Oncologie Hospitalisation | Quimper | 29107 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Institut du Cancer Coulancy Reims | Reims | 51100 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut De Cancerologie Lucien Newrth | Saint-Priest-en-Jarez | 42271 | France |
| Centre Paul Strauss | Strasbourg | 67000 | France |
| Hopitaux Du Leman - Site Georges Pianta | Thonon-les-Bains | 74200 | France |
| Institut Claudius Régaud | Toulouse | 31059 | France |
| CHU Tours - Hôpital Bretonneau | Tours | 37044 | France |
| Hopital Prive Drome Ardeche; Hopital De Jour | Valence | 26000 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Studienzentrum Berlin City | Berlin | 14169 | Germany |
| St. Elisabeth-Krankenhaus | Cologne | 50935 | Germany |
| St. Johannes-Hospital | Dortmund | 44137 | Germany |
| Onkozentrum Dres. Göhler | Dresden | 01127 | Germany |
| BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 01307 | Germany |
| Praxis für Hamatologie und Onkologie | Erfurt | 99085 | Germany |
| Onkodok GmbH | Gütersloh | 33332 | Germany |
| Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe | Hamburg | 22457 | Germany |
| Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard | Hildesheim | 31134 | Germany |
| ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik | Karlsruhe | 76135 | Germany |
| Klinikum Ludwigsburg; Studiensekretariat | Ludwigsburg | 71640 | Germany |
| St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz | Mainz | 55131 | Germany |
| Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde | Mainz | 55131 | Germany |
| Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller | Mayen | 56727 | Germany |
| Klinikum Memmingen; Abt.Gynäkologie | Memmingen | 87700 | Germany |
| Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin | Minden | 32429 | Germany |
| Brustzentrum Rhein-Ruhr Servicegesellschaft mbH | Mönchengladbach | 41061 | Germany |
| Klinikum der Universität München; Frauenklinik - Onkologie II | München | 80336 | Germany |
| Klinikum Neumarkt; Frauenklinik | Neumarkt in der Oberpfalz | 92318 | Germany |
| Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe | Offenbach | 63069 | Germany |
| Johanniter Frauenklinik Stendal Germany | Stendal | 39676 | Germany |
| Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher | Stralsund | 18439 | Germany |
| Universitätsklinik Tübingen; Frauenklinik | Tübingen | 72076 | Germany |
| GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe | Weinheim | 69469 | Germany |
| Marien-Hospital Witten, MVZ Witten | Witten | 58452 | Germany |
| Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe | Worms | 67550 | Germany |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Pamela Youde Nethersole Eastern Hospital; Clinical Oncology | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital Department of Clinical Oncology | Kowloon | Hong Kong |
| National Institute of Oncology, A Dept of Internal Medicine | Budapest | 1122 | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház | Miskolc | 3526 | Hungary |
| Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet | Pécs | 7623 | Hungary |
| Mater Misecordiae University Hospital | Dublin | 7 | Ireland |
| Beaumont Hospital; Cancer Clinical Trials Unit | Dublin | 9 | Ireland |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Med Org Kiryat; Oncology Institute | Jerusalem | 9112000 | Israel |
| Meir Medical center, Pediatrics | Kfar Saba | 4428164 | Israel |
| Rabin MC; Davidof Center - Oncology Institute | Petah Tikva | 4941492 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 5211401 | Israel |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Abruzzo | 24060 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica | Bologna | Emilia-Romagna | 40138 | Italy |
| U.O Medicina Oncologica Ospedale di Carpi | Carpi | Emilia-Romagna | 41012 | Italy |
| Ospedale Degli Infermi - Faenza; Oncologia Medica | Faenza | Emilia-Romagna | 48018 | Italy |
| Azienda Ospedaliero - Universitaria di Modena Policlinico | Modena | Emilia-Romagna | 41110 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43126 | Italy |
| Ospedale degli Infermi | Rimini | Emilia-Romagna | 47923 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Policlinico Universitario Campus Biomedico Di Roma | Rome | Lazio | 00128 | Italy |
| Azienda Ospedaliero Universitaria San Martino | Genoa | Liguria | 16132 | Italy |
| ASST DI LECCO; Oncologia Medica | Lecco | Lombardy | 23900 | Italy |
| Ospedale Mater Salutis | Legnago (VR) | Lombardy | 37045 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Fondazione Salvatore Maugeri | Pavia | Lombardy | 27100 | Italy |
| Policlinico San Mattea | Pavia | Lombardy | 27100 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria | Alessandria | Piedmont | 15121 | Italy |
| Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica | Ponderano (BI) | Piedmont | 13875 | Italy |
| Ospedale Santa Maria Annunziata; Oncologia | Bagno a Ripoli | Tuscany | 50012 | Italy |
| Azienda Usl 7; Dept. Oncologico | Poggibonsi | Tuscany | 53036 | Italy |
| Nuovo Ospedale Di Prato | Prato | Tuscany | 50047 | Italy |
| Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia | Perugia | Umbria | 06100 | Italy |
| Aichi Cancer Center Hospital | Aichi | 464-8681 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Shikoku Cancer Center | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| University of Tsukuba Hospital | Ibaraki | 305-8576 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Fukushima Medical University Hospital | Miyagi | 960-1295 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Naha-nishi Clinic | Okinawa | 901-0154 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| St. Luke's Internat. Hospital, Breast Surgical Oncology | Tokyo | 104-8560 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Iem-Fucam | D.F. | Mexico CITY (federal District) | 04980 | Mexico |
| Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios | Distrito Federal | Mexico CITY (federal District) | 14000 | Mexico |
| Health Pharma Professional Research | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Centro Médico Zambrano Hellion | Monterrey | Nuevo León | 66278 | Mexico |
| Centro de Investigacion Clinica de Oaxaca | Oaxaca City | Oaxaca | 68020 | Mexico |
| Oncologico Potosino | San Luis Potosí City | San Luis Potosí | 78209 | Mexico |
| Merida | Investigacion Clinica | Mérida | Yucatán | 97125 | Mexico |
| CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO | Mexico City | 03100 | Mexico |
| Centro Medico Dalinde | Mexico City | 06700 | Mexico |
| Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology | Arequipa | 04001 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 15038 | Peru |
| Oncosalud Sac; Oncología | Lima | 41 | Peru |
| Instytut MSF Sp. z o.o. | ?ód? | 90-302 | Poland |
| MedPolonia | Poznan | 60-693 | Poland |
| Wielkopolskie Centrum Onkologi | Poznan | 61-866 | Poland |
| Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii | Warsaw | 00-909 | Poland |
| "Filantropia" Clinical Hospital; Gynecological Oncology | Bucharest | 011191 | Romania |
| Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala | Cluj-Napoca | 400015 | Romania |
| Centrul de Oncologie Sfantul Nectarie | Craiova | 200347 | Romania |
| Medsi Clinic | Moscow | Adygeya Republic | 143442 | Russia |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Bashkirian Republican Clinical Oncology Dispensary | Ufa | Bashkortostan Republic | 450054 | Russia |
| Oncologica Dispensary #2 | Sochi | Krasnodarskiy Kray | 354057 | Russia |
| Evimed | Chelyabinsk | Kurgan Oblast | Russia |
| Moscow Clinical Scientific Center | Moscow | Moscow Oblast | 111123 | Russia |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow | Moscow Oblast | 115478 | Russia |
| P.A. Herzen Oncological Inst. ; Oncology | Moscow | Moscow Oblast | 125248 | Russia |
| Nizhny Novgorod Regional Clinical Oncology Center | Nizhny Novgorod | Niznij Novgorod | 603126 | Russia |
| Mordovia State University | Saransk | Respublika Mordoviya | 430032 | Russia |
| National Medical Research Center for Oncology | Rostov-on-Don | Rostov Oblast | 344037 | Russia |
| LLC Strategic Medical Systems | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| EosMed LLC | Saint Petersburg | Sankt-Peterburg | 195197 | Russia |
| Private Healthcare Institution Clinical Hospital RZhD Medicine | Saint Petersburg | Sankt-Peterburg | 195271 | Russia |
| LCC Center of Palliative Medicine - Devita | Saint Petersburg | Sankt-Peterburg | 197343 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint Petersburg | Sankt-Peterburg | Russia |
| Pyatigorsky Oncologic Dispensary | Pyatigorsk | Stavropol Kray | 357524 | Russia |
| Regional Clinical Oncology Hospital | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| Regional Oncology Hospital | Irkutsk | 664035 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Regional Oncology Dispensary; Dept of Chemotherapy | Novgorod Veliky | 173016 | Russia |
| BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic | Omsk | 644013 | Russia |
| Multidisciplinary clinic Reaviz | Samara | 443011 | Russia |
| Samara Regional Oncology Dispensary | Samara | 443031 | Russia |
| Regional Clinical Hospital | Saratov | 410053 | Russia |
| SHI Volgograd Regional Clinical Oncological Dispensary#1 | Volgograd | 400138 | Russia |
| National University Hospital; Medical Oncology | Singapore | 119074 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Soon Chun Hyang University Cheonan Hospital | Dongnam-gu, Cheonan-si | 31151 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| CHA Bundang Medical Center | Gyeonggi-do | 13496 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital; Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Ajou University Hospital | Suwon | 443-721 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Wonju Christian Hospital | Wŏnju | 220-701 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | 08916 | Spain |
| Hospital General De Catalunya; Servicio de Oncologia | Sant Cugat del Vallès | Barcelona | 28981 | Spain |
| Consorci Hospitalari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Hospital Provincial Castellón | Castellon de LA Plana/castello de LA Plana | Castellon | 12002 | Spain |
| Centro Oncologico de Galicia COG; Medical Oncology | A Coruña | LA Coruña | 15009 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid | 28220 | Spain |
| Hospital Infanta Sofia; Servico de Oncologia | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitari Sant Joan de Reus; Planta baja, color lila | Reus | Tarragona | 43204 | Spain |
| Hospital Universitario de Canarias;servicio de Oncologia | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital San Pedro De Alcantara; Servicio de Oncologia | Cáceres | 10003 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Complejo Asistencial Universitario de Leon; Servicio de Oncologia | León | 24071 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28009 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Centro Integral Oncológico Clara Campal Ensayos Clínicos START | Madrid | 28050 | Spain |
| Hosp Univ Fundacion Alcorcon | Madrid | 28922 | Spain |
| Hospital Universitario de Fuenlabrada; Servicio de Oncologia | Madrid | 28943 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | 30120 | Spain |
| Hospital Quirón Sagrado Corazón | Seville | 41013 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia; Servicio de oncologia | Valencia | 46014 | Spain |
| Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia | Zaragoza | 50009 | Spain |
| Hirslanden Medical Center - Tumorzentrum | Aarau | 5000 | Switzerland |
| Centre Hospitalier Universitaire Vaudois - Lausanne | Lausanne | 1011 | Switzerland |
| Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich | Zurich | 8008 | Switzerland |
| Chunghua Christian hospital | Changhua | 500 | Taiwan |
| Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital | Kaoshiung City | 807 | Taiwan |
| E-Da Cancer Hospital; Hematology- Oncology Department | Kaoshiung | 824 | Taiwan |
| Chi Mei Medical Center Liou Ying Campus | Liuying Township | 736 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70457 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital - Taipei Branch | Taipei | 104 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| Chang Gung Medical Foundation Linkou Branch | Taoyuan City | 333 | Taiwan |
| Rajavithi Hospital; Division of Medical Oncology | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital; Medicine/Oncology | Bangkok | 10400 | Thailand |
| Siriraj Hospital; Clinical Research Center, Pharmacy Department | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital | Hat Yai | 90110 | Thailand |
| Srinagarind Hospital, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Lampang Cancer Hospital | Lampang | 52000 | Thailand |
| King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University | Patumwan | 10330 | Thailand |
| Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi | Adana | 01240 | Turkey (Türkiye) |
| Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi | Bursa | 16059 | Turkey (Türkiye) |
| Izmir Ekonomi Universitesi Medical Park Hastanesi | Izmir | 35575 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi | Mersin | 33110 | Turkey (Türkiye) |
| Medikal Park Samsun | Samsun | 55200 | Turkey (Türkiye) |
| Yulis Medical and Diagnostic Center | Zaporizhzhia | Katerynoslav Governorate | 69061 | Ukraine |
| MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department | Dnipro | KIEV Governorate | 49100 | Ukraine |
| Municipal Institution Odesa Regional Oncology Dispensary | Odesa | KIEV Governorate | 65055 | Ukraine |
| Vinnytsya Regional Clinical Oncology Dispensary | Vinnytsia | Podolia Governorate | 21029 | Ukraine |
| Regional Oncology Center; Department of Mammology | Chernihiv | 14029 | Ukraine |
| Chernivtsi Regional Clinical Oncology Dispensary | Chernivtsi | 58013 | Ukraine |
| City Clinical Hospital #4 | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Institution Kirovograd Regional Oncology Dispensary | Kirovograd | 25011 | Ukraine |
| ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department | Kryvyi Rih | 50048 | Ukraine |
| Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| Lviv State Oncological Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Municipal Institution Odesa Regional Clinical Hospital | Odesa | 65025 | Ukraine |
| Sumy Reg. Clin. Oncological Dispensary; Thoracall Department | Sumy | 40005 | Ukraine |
| CCCH City Oncological Center SHEI Uzhgorod NU | Uzhhorod | 88000 | Ukraine |
| Transkarpathian Regional Oncology Clinic; Chemotherapy | Uzhhorod | 88000 | Ukraine |
| Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University | Zaporizhzhya | 69040 | Ukraine |
| NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Calderdale and Huddersfield NHS Foundation Trust | Huddersfield | HD3 3EA | United Kingdom |
| Leeds Teaching Hosp NHS Trust;St James's Institute of Onc | Leeds | LS9 7TF | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Nottingham University Hospitals NHS Trust - City Hospital | Nottingham | NG5 1PB | United Kingdom |
| University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Derived |
| Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. |
| FG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every 3 weeks (Q3W) as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
| Safety Evaluable Population | Safety Evaluable Population included all participants who received any amount of any study drug. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all randomized participants, whether or not the assigned study treatment was received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy | Participants were administered paclitaxel, 80 mg/m^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment. |
| BG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Invasive Disease-Free Survival (iDFS) | iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; & Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3) | iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | PD-L1-positive subpopulation included participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation | iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site [other than the sites mentioned]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | Node positive subpopulation included all participants in the ITT population whose lymph node (LN) status was positive at the time of randomization. ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years) |
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| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization up to death from any cause (up to 5 years) |
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| Secondary | Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer | iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, &/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than sites mentioned]) that has either been histologically confirmed &/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization up to death from any cause (up to 5 years) |
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| Secondary | Recurrence-Free Interval (RFI) | Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional [including invasive ipsilateral tumor and invasive locoregional tumor], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization up to 5 years |
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| Secondary | Distant Recurrence-Free Interval (DRFI) | Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization up to 5 years |
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| Secondary | Disease-Free Survival (DFS) | Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored. | ITT population included all randomized participants, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | months | From randomization up to first disease recurrence or death from any cause (up to 5 years) |
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| Secondary | Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7]) | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement. | Patient-reported outcome (PRO)-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number 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 time point. | Posted | Mean | Standard Deviation | score on scale | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5]) | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, 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) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning. | PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number 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 time point. | Posted | Mean | Standard Deviation | score on scale | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. | PRO-evaluable populations included participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the EORTC QLQC30. ITT population included all randomized participants, whether or not the assigned study treatment was received. Overall number 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 time point. | Posted | Mean | Standard Deviation | score on scale | Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles |
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| Secondary | Number of Participants With Adverse Events (AE) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0. | Safety Evaluable Population included all participants who received any amount of any study drug. | Posted | Count of Participants | Participants | Up to 5 years |
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| Secondary | Serum Concentration of Atezolizumab | Pharmacokinetic (PK)-evaluable population included all participants who received any dose of study medication and who have at least one evaluable postbaseline PK sample. Overall number 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 time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (µg/mL) | Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles |
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| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample. | Safety Evaluable Population included all participants who received any amount of any study drug. Number analyzed at baseline and postbaseline are unique number of participants out of all the assessed participants who may have been ADA positive at that timepoint. Different participants may have contributed data for baseline and postbaseline. | Posted | Number | percentage of participants | Up to 5 years |
|
|
Up to 5 years
All-cause Mortality: ITT population population included all randomized participants, whether or not the assigned study treatment was received.; Adverse Events: Safety Evaluable Population included all participants who received any amount of any study drug.
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 | Chemotherapy | Participants were administered paclitaxel, 80 mg/m^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment. | 58 | 1,098 | 173 | 1,084 | 1,068 | 1,084 |
| EG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. | 72 | 1,101 | 280 | 1,093 | 1,082 | 1,093 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Addison's disease | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Implant site inflammation | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphadenitis bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Vascular access site inflammation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Wound complication | 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 |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Soft tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Lobular breast carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ovarian vein thrombosis | Reproductive system and breast disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Postoperative care | Surgical and medical procedures | MedDRA version 26.1 | Systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Radiation skin injury | 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 |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue 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 |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hot flush | Vascular 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 | Feb 28, 2023 | Jul 29, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D017239 | Paclitaxel |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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 |
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
|
|
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
|
|
|
|
|
|
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
|
| OG001 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m^2 or dose-dense epirubicin, 90 mg/m^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. |
|
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|
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|