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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005490-37 | EudraCT Number |
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This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab Plus Nab-Paclitaxel | Experimental | Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
|
| Placebo Plus Nab-Paclitaxel | Placebo Comparator | Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody | Drug | Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. | Baseline up to approximately 34 months |
| PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. | Baseline up to approximately 34 months |
| Overall Survival (OS) in All Randomized Participants | OS was defined as the time from the date of randomization to the date of death from any cause. | Baseline until death due to any cause (up to approximately 58 months) |
| OS in Participants With Detectable PD-L1 | OS was defined as the time from the date of randomization to the date of death from any cause. | Baseline until death due to any cause (up to approximately 58 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. | Baseline up to approximately 34 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Highlands Oncology Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35695609 | Derived | Li M, Yang B. Prognostic Value of NUSAP1 and Its Correlation with Immune Infiltrates in Human Breast Cancer. Crit Rev Eukaryot Gene Expr. 2022;32(3):45-60. doi: 10.1615/CritRevEukaryotGeneExpr.2021040248. | |
| 33579739 | Derived | Wang H, Ma H, Sove RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2):e002100. doi: 10.1136/jitc-2020-002100. |
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The observation of Overall Survival events was complete. Participants still on treatment were handed over to follow-up programs or studies. The study status is "Completed" but some participants discontinued the study because the Sponsor terminated it after it reached the "Completed" state.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Plus Nab-Paclitaxel | Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
| FG001 | Atezolizumab Plus Nab-Paclitaxel |
| 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 | Jan 31, 2020 | Mar 24, 2021 |
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| Nab-Paclitaxel | Drug | Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity. |
|
|
| Placebo | Drug | Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity. |
|
| Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1 | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. | Baseline up to approximately 34 months |
| Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. | Baseline up to approximately 34 months |
| DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. | Baseline up to approximately 34 months |
| Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. | Baseline up to approximately 58 months |
| TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1 | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. | Baseline up to approximately 58 months |
| Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months) |
| Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | Baseline up to approximately 53 months |
| Maximum Serum Concentration (Cmax) for Atezolizumab | Maximum serum concentration for atezolizumab. | Cycle 1 Day 1 (Cycle = 28 days) |
| Minimum Serum Concentration (Cmin) for Atezolizumab | Minimum serum concentration for atezolizumab. | Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days) |
| Plasma Concentrations of Total Paclitaxel | Plasma Concentrations of Total Paclitaxel | Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days) |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| Kaiser Permanente of Northern California | Oakland | California | 94612 | United States |
| Emad Ibrahim, Md, Inc | Redlands | California | 92373 | United States |
| Univ of Calif, San Francisco; Breast Cancer Center | San Francisco | California | 94115 | United States |
| Kaiser Permanente - San Marcos | San Marcos | California | 92069 | United States |
| Cancer Research Collaboration, Inc. | Santa Ana | California | 92705 | United States |
| Stanford Univ School of Med; Oncology | Stanford | California | 94305-5821 | United States |
| Kaiser Permanente Of Colorado | Aurora | Colorado | 80014 | United States |
| Yale Cancer Center; Medical Oncology | New Haven | Connecticut | 06520 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Stamford Hospital; BCC, MOHR | Stamford | Connecticut | 06904 | United States |
| MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) | Washington D.C. | District of Columbia | 20007 | United States |
| Florida Cancer Specialists - SCRI; Pharmacy | Fort Myers | Florida | 33901 | United States |
| Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | 32256 | United States |
| The Mount Siani Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | United States |
| Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | St. Petersburg | Florida | 33705 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Rush University Medical Center - Chicago | Chicago | Illinois | 60612 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
| Maryland Oncology Hematology | Rochville | Maryland | 20850 | United States |
| Barbara Ann Karmanos Cancer Institute; Oncology | Detroit | Michigan | 48201 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | United States |
| Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC | Kansas City | Missouri | 64132 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New Hampshire Hematology Oncology | Manchester | New Hampshire | 03103 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| ProHEALTH Care Associates LLP | Lake Success | New York | 11042 | United States |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Onc/Hem Care Clin Trials LLC | Cincinnati | Ohio | 45242 | United States |
| The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc. | Columbus | Ohio | 43219 | United States |
| Kaiser Perm NW - Rheuma | Portland | Oregon | 97227 | United States |
| Providence Cancer Center | Portland | Oregon | 97231 | United States |
| St. Luke's Cancer Care Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Greenville Health System (GHS) Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Wellmont Bristol Regional Medical Center | Bristol | Tennessee | 37620 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Texas Oncology- El Paso Cancer Treatment Center Gateway | El Paso | Texas | 79915 | United States |
| The Methodist Cancer Center | Houston | Texas | 77030 | United States |
| University of Texas;M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Inova Medical Group | Fairfax | Virginia | 22031 | United States |
| Cancer Care Northwest | Spokane | Washington | 99204 | United States |
| Centro de Oncologia e Investigacion Buenos Aires (COIBA) | Buenos Aires | B1884BBF | Argentina |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Nepean Cancer Care Centre | Sydney | New South Wales | 2747 | Australia |
| Icon Cancer Foundation | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital; Division of Cancer Services | Woolloongabba | Queensland | 4102 | Australia |
| Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | 3199 | Australia |
| Peter MacCallum Cancer Centre; Medical Oncology | Melbourne | Victoria | 3000 | Australia |
| Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| St John of God Hospital; Bendat Cancer Centre | Subiaco | Western Australia | 6008 | Australia |
| Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I | Graz | 8036 | Austria |
| Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1 | Linz | 4010 | Austria |
| A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie | Steyr | 4400 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I | Vienna | 1090 | Austria |
| Institut Jules Bordet | Anderlecht | 1070 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| GHdC Site Notre Dame | Charleroi | 6000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | 7100 | Bosnia and Herzegovina |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-550 | Brazil |
| Santa Casa de Misericordia de Salvador | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital de Caridade de Ijui; Oncologia | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro de Pesquisas Oncologicas - CEPON | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Hospital Sao Jose | São Paulo | São Paulo | 01321-001 | Brazil |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K2H 6C2 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital du Saint Sacrement | Québec | Quebec | G1S 4L8 | Canada |
| Centro de Cancer Pontificie Universidad Catolica de Chile | Santiago | 8330074 | Chile |
| Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | 4810469 | Chile |
| Clinica del Country | Bogotá | 11001 | Colombia |
| Oncomedica S.A. | Montería | 230002 | Colombia |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| North Estonia Medical Centre Foundation; Oncology Centre | Tallinn | 13419 | Estonia |
| Tartu Uni Hospital; Hematology - Oncology Clinic | Tartu | 51014 | Estonia |
| Tampere University Hospital; Dept of Oncology | Tampere | 33520 | Finland |
| Ico - Paul Papin | Angers | 49000 | France |
| Institut Sainte Catherine | Avignon | 84082 | France |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale | Grenoble | 38043 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Clinique Catherine de Sienne | Nantes | 44202 | France |
| Institut Curie | Paris | 75005 | France |
| Hopital La Pitie Salpetriere | Paris | 75013 | France |
| Institut De Cancerologie De L'Ouest; Medical Oncology | Saint-Herblain | 44115 | France |
| Centre Paul Strauss | Strasbourg | 67000 | France |
| Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters | Berlin | 13581 | Germany |
| St. Elisabeth-Krankenhaus; Brustzentrum | Cologne | 50935 | Germany |
| St. Johannes Hospital; Abt. für Hämatologie und Onkologie | Dortmund | 44137 | Germany |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Erlangen; Frauenklinik | Erlangen | 91054 | Germany |
| Uniklinik Essen; Gynäkologie | Essen | 45122 | Germany |
| Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH | Georgsmarienhütte | 49124 | Germany |
| Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | 20246 | Germany |
| Facharztzentrum Eppendorf, Studien GbR | Hamburg | 20249 | Germany |
| Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen | Heidelberg | 69120 | Germany |
| Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin | Koblenz | 56068 | Germany |
| Universitätsklinikum Schleswig-Holstein; Campus Lübeck | Lübeck | 23538 | Germany |
| Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde | München | 81675 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Münster | 48153 | Germany |
| MVZ Nordhausen gGmbH, Praxis Dr. Grafe | Nordhausen | 99734 | Germany |
| Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie | Recklinghausen | 45659 | Germany |
| Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie | Trier | 54290 | Germany |
| Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis | Troisdorf | 53840 | Germany |
| Universitätsklinik Tübingen; Frauenklinik & Poliklinik | Tübingen | 72076 | Germany |
| Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | 115 22 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| Univ General Hosp Heraklion; Medical Oncology | Heraklion | 711 10 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | 546450 | Greece |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Queen Mary Hospital; Dept of Medicine | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | 1122 | Hungary |
| Fövárosi Önkormányzat uzsoki utcai Kórház | Budapest | 1145 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont | Szeged | 6720 | Hungary |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica | Naples | Campania | 80131 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica | Milan | Lombardy | 20141 | Italy |
| Aichi Cancer Center Hospital | Aichi | 464-8681 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Gunma Prefectural Cancer Center | Gunma | 373-8550 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| St. Marianna University Hospital | Kanagawa | 216-8511 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Mie University Hospital | Mie | 514-8507 | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | 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 |
| Kindai University Hospital | Osaka | 589-8511 | 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 |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| St. Luke's International Hospital | Tokyo | 104-8560 | Japan |
| Komagome Hospital | Tokyo | 113-8677 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Daugavpils Regional Hospital | Daugavpils | 5417 | Latvia |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| Centro Medico Dalinde | Mexico City | Mexico CITY (federal District) | 06760 | Mexico |
| Centro Médico Zambrano Hellion | Monterrey | Nuevo León | 66278 | Mexico |
| Instituto Estatal de Cancerologia Colima | Colima | 28000 | Mexico |
| Iem-Fucam | D.F. | 04980 | Mexico |
| Consultorio de Medicina Especializada; Dentro de Condominio San Francisco | Mexico City | 03100 | Mexico |
| Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk | Bergen | Norway |
| Sørlandet Sykehus Kristiansand | Kristiansand | 4604 | Norway |
| Stavanger Universitetssykehus, Helse Stavanger HF | Stavanger | 4011 | Norway |
| Centro Oncológico de Panamá | Panama City | 0801 | Panama |
| Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii | Bydgoszcz | 85-796 | Poland |
| Szpitale Wojewodzkie w Gdyni Sp. z o.o. | Gdynia | 81-519 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii | Lublin | 20-090 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr | Warsaw | 02-781 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| Oncomed SRL | Timișoara | 300239 | Romania |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Main Military Clinical Hospital named after N.N. Burdenko | Moscow | Moscow Oblast | 105229 | Russia |
| Blokhin Cancer Research Center; Combined Treatment | Moskva | Moscow Oblast | 115478 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | 197758 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| National Cancer Center | Goyang-si | 10408 | 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 |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | 08907 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Sodersjukhuset; Onkologkliniken | Stockholm | 118 83 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 751 85 | Sweden |
| Universitaetsspital Basel; Onkologie | Basel | 4031 | Switzerland |
| Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum | Sankt Gallen | 9007 | Switzerland |
| Universitätsspital Zürich | Zurich | 8038 | Switzerland |
| Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital; Surgery | Taichung | 404 | Taiwan |
| VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital; General Surgery | Taipei | 100 | Taiwan |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital; Department of Oncology | Songkhla | 90110 | Thailand |
| Cukurova Uni Faculty of Medicine; Medical Oncology | Adana | 01330 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department | Istanbul | 34098 | Turkey (Türkiye) |
| Medipol University MF; Oncology Department | Istanbul | 34214 | Turkey (Türkiye) |
| Ege Uni Medical Faculty Hospital; Oncology Dept | Izmir | 35100 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye/Ankara | 06230 | Turkey (Türkiye) |
| Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipropetrovsk | 49102 | Ukraine |
| Kyiv City Clinical Oncological Center | Kyiv | 03115 | Ukraine |
| Treatment and Prevention Institution Volyn Regional Oncology Dispensary | Lutsk | 43018 | Ukraine |
| Lviv State Oncology Regional Treatment and Diagnostic Centre | Lviv | 79031 | Ukraine |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| Western General Hospital; Clinical Oncology | Edinburgh | EH4 2XU | United Kingdom |
| St Bartholomew's Hospital | London | EC1M 6BQ | United Kingdom |
| Guys ST Thomas Hospital | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital - London | London | SW3 6JJ | United Kingdom |
| Christie Hospital Nhs Trust; Medical Oncology | Manchester | M2O 4BX | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Preston Hosptial | Preston | PR2 9HT | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| 32178964 | Derived | Adams S, Dieras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20. |
| 31786121 | Derived | Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27. |
| 30345906 | Derived | Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20. |
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Plus Nab-Paclitaxel | Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
| BG001 | Atezolizumab Plus Nab-Paclitaxel | Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. |
| 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 | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. | The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 34 months |
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| Primary | PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) | PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first. | The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 34 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) in All Randomized Participants | OS was defined as the time from the date of randomization to the date of death from any cause. | The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 58 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | OS in Participants With Detectable PD-L1 | OS was defined as the time from the date of randomization to the date of death from any cause. | The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization. | Posted | Median | 95% Confidence Interval | Months | Baseline until death due to any cause (up to approximately 58 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. | The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline. | Posted | Number | Percentage of Participants | Baseline up to approximately 34 months |
|
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| Secondary | Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1 | An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1. | The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline. | Posted | Number | Percentage of participants | Baseline up to approximately 34 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. | The duration of response (DOR)-evaluable population is defined as patients with an objective response. | Posted | Number | 95% Confidence Interval | Months | Baseline up to approximately 34 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 | DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first. | The duration of response (DOR)-evaluable population is defined as patients with an objective response. | Posted | Number | 95% Confidence Interval | Months | Baseline up to approximately 34 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. | The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 58 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1 | Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment. | The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 58 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | The safety-evaluable population is defined as participants who received any amount of any study drug. | Posted | Number | Percentage of participants | Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | The anti-drug antibodies (ADA)-evaluable population is defined as all patients treated with atezolizumab who have at least one post-baseline ADA result. | Posted | Number | Percentage of participants | Baseline up to approximately 53 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration (Cmax) for Atezolizumab | Maximum serum concentration for atezolizumab. | The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available. | Posted | Mean | Standard Deviation | µg/mL | Cycle 1 Day 1 (Cycle = 28 days) |
|
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| Secondary | Minimum Serum Concentration (Cmin) for Atezolizumab | Minimum serum concentration for atezolizumab. | The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available. | Posted | Mean | Standard Deviation | µg/mL | Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Total Paclitaxel | Plasma Concentrations of Total Paclitaxel | The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days) |
|
|
From the first study drug to the data cutoff date: 31 August 2021 (up to approximately 74 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious & other adverse events reported based on safety population, which included participants who received any amount of any study drug. In placebo+nab-paclitaxel arm, 6 participants received atezolizumab in error & 9 participants crossed over from placebo+nab-paclitaxel arm to atezolizumab+nab-paclitaxel arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (q2w) + Nab-Paclitaxel | Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. | 333 | 451 | 80 | 430 | 414 | 430 |
| EG001 | Atezolizumab (q2w) + Nab-Paclitaxel | Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity. | 314 | 451 | 110 | 460 | 450 | 460 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ADDISON'S DISEASE | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ADRENOCORTICAL INSUFFICIENCY ACUTE | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOPHYSITIS | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| KERATITIS | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| OPTIC NEUROPATHY | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTROINTESTINAL TOXICITY | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MECHANICAL ILEUS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| ILL-DEFINED DISORDER | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
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| AUTOIMMUNE CHOLANGITIS | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| BILE DUCT STONE | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| CHOLECYSTOCHOLANGITIS | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| HEPATITIS | Hepatobiliary disorders | MedDRA version 24.0 | Systematic Assessment |
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| CONTRAST MEDIA ALLERGY | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
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| SYSTEMIC IMMUNE ACTIVATION | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| MASTITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| STREPTOCOCCAL SEPSIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LIMB DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| TEMPOROMANDIBULAR JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INFECTED NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| MALIGNANT ASCITES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 24.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CEREBRAL THROMBOSIS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HEPATIC ENCEPHALOPATHY | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| IIIRD NERVE PARALYSIS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DEVICE BREAKAGE | Product Issues | MedDRA version 24.0 | Systematic Assessment |
| |
| THROMBOSIS IN DEVICE | Product Issues | MedDRA version 24.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| STRIDOR | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DERMATOMYOSITIS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LICHEN PLANUS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| TOXIC EPIDERMAL NECROLYSIS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PERIPHERAL EMBOLISM | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BELL'S PALSY | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| BREAST PAIN | Reproductive system and breast disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| NAIL DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2017 | Mar 24, 2021 | 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 |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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