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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003208-59 | EudraCT Number |
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This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Atezolizumab + Paclitaxel + Carboplatin | Experimental | The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant. |
|
| Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | Experimental | The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant. |
|
| Arm C: Nab-Paclitaxel + Carboplatin | Active Comparator | The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody | Drug | Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population. | Up to approximately 30 months after first participant enrolled |
| Overall Survival (OS) in the ITT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT population. | Up to approximately 39 months after first participant enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| OS in the in the Teff Population | OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population. | Up to approximately 39 months after first participant enrolled |
| PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population |
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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 |
|---|---|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | United States | ||
| Highlands Oncology Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35511917 | Derived | Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471. |
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'Study Terminated By Sponsor' Reason for Not Completed is a data entry error; reason for not completed is unknown. The study was Completed and not Terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm C: Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care. |
| 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 | Oct 24, 2018 | Sep 25, 2019 |
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| Carboplatin | Drug | Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles. |
|
| Nab-Paclitaxel | Drug | Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles. |
|
| Paclitaxel | Drug | Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV. |
|
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population. |
| Up to approximately 30 months after first participant enrolled |
| PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population. | Up to approximately 30 months after first participant enrolled |
| PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population. | Up to approximately 30 months after first participant enrolled |
| OS in the TC2/3 or IC2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population. | Up to approximately 39 months after first participant enrolled |
| OS in the TC1/2/3 or IC1/2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population. | Up to approximately 39 months after first participant enrolled |
| Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Proportion of participants with an objective response (CR or PR) in the ITT population. | Up to approximately 30 months after first participant enrolled |
| Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population. | Up to approximately 30 months after first participant enrolled |
| Event Free Rate at 1 and 2 Years in the ITT Population | Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population. | 1 and 2 years |
| Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population | TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems. | Up to approximately 30 months after first participant enrolled |
| TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population | TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a >= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a >= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A >= 10-point change in the EORTC scale score is perceived by patients as clinically significant. | Up to approximately 30 months after the first participant enrolled |
| Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease) | Baseline up to approximately 30 months after first participant enrolled |
| PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B) | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B. | Up to approximately 30 months after first participant enrolled |
| OS in the ITT Population (Arm A and Arm B) | OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B. | Up to approximately 39 months after first participant enrolled |
| Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | Up to approximately 68 months after first participant enrolled |
| Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab | Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab. | Up to approximately 30 months after first participant enrolled |
| Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) |
| Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration. | Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days) |
| Plasma Concentrations for Paclitaxel | Plasma concentrations for paclitaxel. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
| Plasma Concentrations for Nab-Paclitaxel | Plasma concentrations for nab-paclitaxel. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
| Plasma Concentrations for Carboplatin | Plasma concentrations for carboplatin. | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| Southern CA Permanente Med Grp | Bellflower | California | United States |
| Kaiser Permanente Oakland Medical Center | Oakland | California | 94611 | United States |
| Kaiser Permanente - Sacramento Medical Center and Medical Offices | Sacramento | California | 95825 | United States |
| Kaiser Permanente - San Leandro Medical Center | San Leandro | California | 94577 | United States |
| Kaiser Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente; Oncology Clinical Trials | Vallejo | California | 94589 | United States |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Holy Cross Hospital Inc | Fort Lauderdale | Florida | 33308 | United States |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33916 | United States |
| Florida Cancer Specialists | Palm Beach Gardens | Florida | 33410 | United States |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | St. Petersburg | Florida | 33705 | United States |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | United States |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton | Georgia | 30117 | United States |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | United States |
| Southeastern Regional Medical Center, Inc. | Newnan | Georgia | 30265 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Joliet Oncology-Hematology; Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana | 46845 | United States |
| Hematology-Oncology; Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Siouxland Hematology/Oncology | Sioux City | Iowa | 51101 | United States |
| Lahey Clinic Med Ctr | Lexington | Kentucky | 02421 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| Southcoast Health System; Southcoast Centers For Cancer Care | Fairhaven | Massachusetts | 02719 | United States |
| St. Joseph Mercy Health System | Ann Arbor | Michigan | 48106 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| St. Luke's Regional Cancer Center | Duluth | Minnesota | 55805 | United States |
| Hematology and Oncology Associates at Bridgepoint | Tupelo | Mississippi | 38801 | United States |
| Billings Clinic | Billings | Montana | 59102 | United States |
| Valley Hospital; Oncology Research | Paramus | New Jersey | 07652 | United States |
| Regional Cancer Care Associates LLC | Sewell | New Jersey | 08080 | United States |
| Clinical Research Alliance | Westbury | New York | 11590 | United States |
| W.G. Bill Hefner VA Medical Center | Salisbury | North Carolina | United States |
| University of Cincinnati | Cincinnati | Ohio | 45203-0542 | United States |
| Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Oncology Hematology Care, Inc. | Hamilton | Ohio | 45103 | United States |
| Oregon Health & Science Uni | Portland | Oregon | 97239 | United States |
| St. Luke's Cancer Care Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Maryland Oncology Hematology (Lanham) - USOR | Gettysburg | Pennsylvania | 17325 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Univ of Pittsburgh Medical Ctr | Pittsburgh | Pennsylvania | 15232 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37920 | United States |
| SCRI The Center For Cancer and Blood Disorders | Denton | Texas | 76210 | United States |
| Longview Cancer Center | Longview | Texas | 75601 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
| Medical Oncology Associates | Spokane | Washington | 99208 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | F5300COE | Argentina |
| Clínica Pergamino | Pergamino | B2700CPM | Argentina |
| Fundacion Koriza | Santa Rosa | L6304BOC | Argentina |
| Centro de Investigacion; Clinica - Clinica Viedma S.A. | Viedma | R8500ACE | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Townsville Hospital | Townsville | Queensland | 4810 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Cabrini Hospital Malvern | Malvern | Victoria | 3144 | Australia |
| Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Paracelsus Medizinische Privatuniversität | Salzburg | 5020 | Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Clinique Ste-Elisabeth | Namur | 5000 | Belgium |
| Werken Glorieux VZW | Ronse | 9600 | Belgium |
| GasthuisZusters Antwerpen | Wilrijk | 2610 | Belgium |
| Cenantron - Centro Avancado de Tratamento Oncologico | Belo Horizonte | Minas Gerais | 30130-090 | Brazil |
| Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica | Londrina | Paraná | 86 015 520 | Brazil |
| Liga Norte Riograndense Contra O Câncer | Natal | Rio Grande do Norte | 59040150 | Brazil |
| IPCEM; Instituto de Pesquisa de Estudos Multicêntricos | Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Hospital Bruno Born | Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90470-340 | Brazil |
| *X*Fundação Pio XII Hospital de Câncer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital Do Cancer A C Camargo | São Paulo | São Paulo | 01525-001 | Brazil |
| Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | 4000 | Bulgaria |
| Multiprofile Hospital for Active Treatment Serdika EOOD | Sofia | 1303 | Bulgaria |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| William Osler Health Centre | Etobicoke | Ontario | M9V 1R8 | Canada |
| Lakeridge Health Center | Oshawa | Ontario | L1J 2J2 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| Hôpital du Sacré-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| St. Jerome Medical Research | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Health & Care SPA | Santiago | 7500006 | Chile |
| Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | 4810469 | Chile |
| CHU de Grenoble | Grenoble | 38043 | France |
| Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd | Le Mans | 72000 | France |
| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes | Lyon | 69008 | France |
| Clinique Clémentville | Montpellier | 34070 | France |
| Hopital de La Source | Orléans | 45067 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital de Pontchaillou; Service de Pneumologie | Rennes | 35033 | France |
| Centre Hospitalier Regional Sud Reunion; Service de Pneumologie | Saint-Pierre | 97448 | France |
| CH de Saint Quentin | Saint-Quentin | 2100 | France |
| Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques | Toulon | 83800 | France |
| Charite - Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie | Bielefeld | 33611 | Germany |
| Augusta Kranken-Anstalt gGmbH | Bochum | 44791 | Germany |
| Kliniken der Stadt Koln gGmbH | Cologne | 51109 | Germany |
| Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | 01307 | Germany |
| St. Elisabethen Krankenhaus | Frankfurt am Main | 60487 | Germany |
| Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie | Gerlingen | 70839 | Germany |
| LungenClinic Großhansdorf GmbH | Großhansdorf | 22927 | Germany |
| Krankenhaus Martha-Maria; Halle-Dolau gGmbH | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Harburg | Hamburg | 21075 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Universität Des Saarlandes; Klinik für Innere Medizin V | Homburg | 66421 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin | Minden | 32429 | Germany |
| Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie | München | 81925 | Germany |
| Krankenhaus Barmherzige Bruder Regensburg | Regensburg | 93049 | Germany |
| Klinikum der Universität Regensburg | Regensburg | 93053 | Germany |
| Stiftung Mathias-Spital Rheine | Rheine | 48431 | Germany |
| Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie | Villingen-Schwenningen | 78052 | Germany |
| Soroka Medical Center | Beersheba | 8410101 | Israel |
| Hadassah University Hospital - Ein Kerem | Jerusalem | 9112001 | Israel |
| Meir Medical Center; Oncology | Kfar Saba | 4428164 | Israel |
| Rabin Medical Center | Petach Tiqwa | 4941492 | Israel |
| Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | 5262100 | Israel |
| Rambam Health Corporation; Oncology Institute | Rambam | 3525408 | Israel |
| Tel Aviv Sourasky Medical Ctr; Oncology | Tel Aviv | 6423906 | Israel |
| IRCCS Giovanni Paolo II Istituto Oncologico | Bari | Apulia | 70124 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati | Avellino | Campania | 83100 | Italy |
| AORN A Cardarelli | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata | Naples | Campania | 80131 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| ASL 3 Genovese; DSM | Genoa | Liguria | 16147 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardy | 27100 | Italy |
| Policlinico Vittorio Emanuele | Catania | Sicily | 95123 | Italy |
| Ospedale Civile - Livorno | Livorno | Tuscany | 57124 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Ospedale Silvestrini | Perugia | Umbria | 06122 | Italy |
| Aichi Cancer Center Hospital; Respiratory Medicine | Aichi | 464-8681 | Japan |
| Nagoya University Hospital; Respiratory Medicine | Aichi | 466-8560 | Japan |
| National Cancer Center Hospital East; Thoracic Oncology | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center; Internal Medicine | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine | Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital; Respiratory | Fukuoka | 812-8582 | Japan |
| Kobe City Medical Center General Hospital; Respiratory Medicine | Hyōgo | 650-0047 | Japan |
| National Hospital Organization Himeji Medical Center | Hyōgo | 670-8520 | Japan |
| Hyogo Cancer Center; Thoracic Oncology | Hyōgo | 673-8558 | Japan |
| Ibaraki Prefectural Central Hospital; Division of respiratory | Ibaraki | 309-1793 | Japan |
| Kanagawa Cancer Center;Thoracic Oncology | Kanagawa | 241-8515 | Japan |
| Kyoto University Hospital, Respiratory Medicine | Kyoto | 606-8507 | Japan |
| Sendai Kousei Hospital; Pulmonary Medicine | Miyagi | 980-0873 | Japan |
| Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease | Niigata | 951-8520 | Japan |
| Okayama University Hospital; Respiratory and Allergy Medicine | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute; Thoracic Oncology | Osaka | 541-8567 | Japan |
| Osaka City Uni Hospital; Respiratory Medicine | Osaka | 545-8586 | Japan |
| Kansai Medical university Hospital; Thoracic Oncology | Osaka | 573-1191 | Japan |
| Osaka Habikino Medical Center | Osaka | 583-8588 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakaishi | 591-8555 | Japan |
| Saitama Cancer Center; Thoracic Oncology | Satima | 362-0806 | Japan |
| Shizuoka Cancer Center; Thoracic Oncology | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital; Thoracic Medical Oncology | Tokyo | 104-0045 | Japan |
| Tokyo Medical University Hospital; Dept of Surgery | Tokyo | 160-0023 | Japan |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002 | Latvia |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| National Cancer Institute | Vilnius | 08660 | Lithuania |
| Centro Universitario Contra El Cancer | Monterrey | 64020 | Mexico |
| Cancerología | Querétaro | 76090 | Mexico |
| VU Medisch Centrum; VU University Medical Center | Amsterdam | 1007 MB | Netherlands |
| Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Ziekenhuis Gelderse Vallei | Ede | 6716 RP | Netherlands |
| Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose | Eindhoven | 5623 EJ | Netherlands |
| St. Antonius Ziekenhuis; R&D Long | Nieuwegein | 3435 CM | Netherlands |
| Centro Medico Monte Carmelo | Arequipa | 04001 | Peru |
| Hospital Nacional Guillermo Almenara Irigoyen ESSALUD | Lima | Lima 13 | Peru |
| Instituto Regional de Enfermedades Neoplásicas Del Norte | Trujillo | 12345 | Peru |
| IPO de Lisboa; Servico de Pneumologia | Lisbon | 1099-023 | Portugal |
| Hospital Pulido Valente; Servico de Pneumologia | Lisbon | 1796-001 | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo António | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Porto | 4200-072 | Portugal |
| Hospital de Sao Joao; Servico de Pneumologia | Porto | 4200 | Portugal |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Russian Oncology Research Center n.a. N.N. Blokhin | Moscow | 115478 | Russia |
| Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 197022 | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | 400138 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Univerzitna nemocnica Bratislava | Bratislava | 813 69 | Slovakia |
| Narodny onkologicky ustav | Bratislava | 833 10 | Slovakia |
| POKO Poprad s.r.o. | Poprad | 058 01 | Slovakia |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | LA Coruña | 15006 | Spain |
| Complejo Hospitalario Universitario Insular-Materno Infantil | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Hospital Nuestra Senora de Valme | Seville | Sevilla | 41014 | Spain |
| Hospital Universitario de Canarias | S. Cristobal de La Laguna | Tenerife | 38320 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14008 | Spain |
| Hospital Lucus Augusti; Servicio de Oncologia | Lugo | 27003 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 280146 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Fundación Jimenez Díaz | Madrid | 28040 | Spain |
| Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Changhua Christian Hospital; Hematology-Oncology | Changhua | 500 | Taiwan |
| Kaohsiung Medical University Hospital; Department of Urology | Kaohsiung City | 807 | Taiwan |
| Chi Mei Medical Center Liou Ying Campus | Liuying Township | 736 | Taiwan |
| Chang Gung Memorial Hospital Chiayi | Putzu | 613 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 10041 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy | Dnipropetrovsk | Katerynoslav Governorate | 49102 | Ukraine |
| Uzhgorod Central City Clinical Hospital | Uzhhorod | Katerynoslav Governorate | 88000 | Ukraine |
| MNPE Zaporizhzhia Regional Antitumor Center ZRC | Zaporizhzhia | Katerynoslav Governorate | 69040 | Ukraine |
| Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council | Vinnytsia | KIEV Governorate | 21029 | Ukraine |
| MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy | Lviv | Volhynian Governorate | 79031 | Ukraine |
| Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1 | Chernivtsi | 58013 | Ukraine |
| SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine | Kharkiv | 61024 | Ukraine |
| ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department | Kryvyi Rih | 50048 | Ukraine |
| Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department | Poltava | 36011 | Ukraine |
| Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary | Sumy | 40005 | Ukraine |
| FG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| FG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm C: Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care. |
| BG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| BG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Primary | Overall Survival (OS) in the ITT Population | OS is defined as the time between the date of randomization and date of death from any cause in the ITT population. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 39 months after first participant enrolled |
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| Secondary | OS in the in the Teff Population | OS is defined as the time between the date of randomization and date of death from any cause in the in the Teff Population. | The Teff (>=-1.91) population and the Teff (<-1.91) population, defined as patients in the ITT population with Teff signature expression >=-1.91 and <-1.91, respectively. | Posted | Median | 95% Confidence Interval | Month | Up to approximately 39 months after first participant enrolled |
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| Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Teff Population. | The Teff (>=-1.91) population and the Teff (<-1.91) population, defined as patients in the ITT population with Teff signature expression >=-1.91 and <-1.91, respectively. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population. | The PD-L1 TC2/3 or IC2/3 population is defined as particpants in the ITT population with PD-L1 TC2/3 or IC2/3 expression in baseline tumor tissue. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the TC1/2/3 or IC1/2/3 Population. | The PD-L1 TC1/2/3 or IC1/2/3 population is defined as participants in the ITT population with PD-L1 TC1/2/3 or IC1/2/3 expression in baseline tumor tissue. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | OS in the TC2/3 or IC2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause, in the TC2/3 or IC2/3 Population. | The PD-L1 TC2/3 or IC2/3 population is defined as particpants in the ITT population with PD-L1 TC2/3 or IC2/3 expression in baseline tumor tissue. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 39 months after first participant enrolled |
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| Secondary | OS in the TC1/2/3 or IC1/2/3 Population | OS is defined as the time between the date of randomization and date of death from any cause in the TC1/2/3 or IC1/2/3 Population. | The PD-L1 TC1/2/3 or IC1/2/3 population is defined as participants in the ITT population with PD-L1 TC1/2/3 or IC1/2/3 expression in baseline tumor tissue. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 39 months after first participant enrolled |
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| Secondary | Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Proportion of participants with an objective response (CR or PR) in the ITT population. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Number | Percentage of participants | Up to approximately 30 months after first participant enrolled |
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| Secondary | Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population | Duration of response is defined as the time from the first documented objective response to documented PD or death from any cause, whichever occurred first, in the ITT Population. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | Event Free Rate at 1 and 2 Years in the ITT Population | Event free rate at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population. | Participants still alive at 1 or 2 years after randomization from the ITT population. | Posted | Number | Percentage of participants | 1 and 2 years |
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| Secondary | Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population | TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population. The EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC scales and single-item measures will be linearly transformed so that each score has a range of 0-100. A high score for a functional scale represents a high or healthy level of functioning, and a high score for the global health status and HRQoL represents a high HRQoL; however, a high score for a symptom scale or item represents a high level of symptomatology or problems. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population | TTD was documented for a 3-symptom composite endpoint using the following EORTC QLQ-LC13 symptom scores: cough, chest pain, and dyspnea multi--item scale. In this instance, symptom deterioration will be determined as a >= 10-point increase above baseline in any of the listed symptom scores, whichever occurs first (cough, chest pain, and dyspnea multi-item scale). Confirmed clinically meaningful symptom deterioration will need to be held for the original symptom; a >= 10-point increase above baseline in a symptom score must be held for at least two consecutive assessments or an initial>=10-point increase above baseline followed by death within 3 weeks from the last assessment. A >= 10-point change in the EORTC scale score is perceived by patients as clinically significant. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after the first participant enrolled |
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| Secondary | Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population | Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for chest pain score is considered to be clinically significant. (Note: PD=progression of disease) | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to approximately 30 months after first participant enrolled |
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| Secondary | PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B) | PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT Population Arm A and Arm B. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 30 months after first participant enrolled |
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| Secondary | OS in the ITT Population (Arm A and Arm B) | OS is defined as the time between the date of randomization and date of death from any cause in the ITT Population, Arm A and Arm B. | Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 39 months after first participant enrolled |
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| Secondary | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | The safety population included all treated patients, defined as randomized patients who received any protocol treatment. | Posted | Number | Percentage of participants | Up to approximately 68 months after first participant enrolled |
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| Secondary | Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab | Percentage of participants with Anti-therapeutic Antibody (ATA) response to atezolizumab. | The baseline ADA evaluable population for each study treatment included participants who had a baseline ADA result. The post-baseline ADA evaluable population for each study treatment included participants who had at least one post baseline ADA result and who had received at least one dose of that study treatment. | Posted | Number | Percentage of participants | Up to approximately 30 months after first participant enrolled |
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| Secondary | Maximum Observed Serum Atezolizumab Concentration (Cmax) | Maximum observed serum atezolizumab concentration (Cmax). The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | The pharmacokinetic evaluable population is defined as all participants who received any dose of atezolizumab, carboplatin, paclitaxel, or nab paclitaxel and who had evaluable PK samples post-dose. | Posted | Mean | Standard Deviation | µg/mL | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days) |
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| Secondary | Minimum Observed Serum Atezolizumab Concentration (Cmin) | Minimum observed serum atezolizumab concentration (Cmin). The predose samples will be collected on the same day of treatment administration. | The pharmacokinetic evaluable population is defined as all participants who received any dose of atezolizumab, carboplatin, paclitaxel, or nab paclitaxel and who had evaluable PK samples post-dose. | Posted | Mean | Standard Deviation | µg/mL | Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 30 months), at treatment discontinuation (up to 30 months), and at 120 days after the last dose of atezolizumab (up to approximately 30 months, each cycle is 21 days) |
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| Secondary | Plasma Concentrations for Paclitaxel | Plasma concentrations for paclitaxel. | The pharmacokinetic evaluable population is defined as all participants who received any dose of atezolizumab, carboplatin, paclitaxel, or nab paclitaxel and who had evaluable PK samples post-dose. | Posted | Mean | Standard Deviation | ng/mL | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
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| Secondary | Plasma Concentrations for Nab-Paclitaxel | Plasma concentrations for nab-paclitaxel. | The pharmacokinetic evaluable population is defined as all participants who received any dose of atezolizumab, carboplatin, paclitaxel, or nab paclitaxel and who had evaluable PK samples post-dose. | Posted | Mean | Standard Deviation | ng/mL | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
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| Secondary | Plasma Concentrations for Carboplatin | Plasma concentrations for carboplatin. | The pharmacokinetic evaluable population is defined as all participants who received any dose of atezolizumab, carboplatin, paclitaxel, or nab paclitaxel and who had evaluable PK samples post-dose. | Posted | Mean | Standard Deviation | ng/mL | Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days) |
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From the first study drug administration to the data cutoff date: 17 February 2021 (up to approximately 68 months).
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received at least one dose of any study medication.
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 | Arm C: Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care. | 252 | 340 | 96 | 334 | 315 | 334 |
| EG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. | 245 | 343 | 168 | 334 | 325 | 334 |
| EG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. | 243 | 338 | 151 | 332 | 315 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HAEMOLYSIS | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ANGINA UNSTABLE | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ARRHYTHMIA | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ATRIAL THROMBOSIS | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| TRACHEO-OESOPHAGEAL FISTULA | Congenital, familial and genetic disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOPITUITARISM | Endocrine disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DUODENAL PERFORATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTROINTESTINAL NECROSIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTROINTESTINAL TOXICITY | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PANCREATITIS CHRONIC | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEATH | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PAIN | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HEPATITIS TOXIC | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| IMMUNE-MEDIATED HEPATITIS | Hepatobiliary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS | Immune system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL SEPSIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHRONIC HEPATITIS C | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| COLONIC ABSCESS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFECTED DERMAL CYST | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| LUNG ABSCESS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PLEURAL INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA HAEMOPHILUS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PULMONARY SEPSIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| STOMATOCOCCAL INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHEST INJURY | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| PERIORBITAL HAEMATOMA | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| RADIATION OESOPHAGITIS | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| RADIATION PNEUMONITIS | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MeDRA Version 23.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| BLOOD LACTIC ACID INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| POLYMYOSITIS | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| BENIGN SALIVARY GLAND NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| GALLBLADDER ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| INFECTED NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| TUMOUR EMBOLISM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA Version 23.1 | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HEMIPLEGIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPERAESTHESIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOTONIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MOTOR DYSFUNCTION | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MYXOEDEMA COMA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEVICE DISLOCATION | Product Issues | MeDRA Version 23.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| BRONCHIAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DIAPHRAGMATIC PARALYSIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DYSPNOEA AT REST | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| IMMUNE-MEDIATED PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LARYNGEAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PARANASAL CYST | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PNEUMOTHORAX SPONTANEOUS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| THERAPEUTIC EMBOLISATION | Surgical and medical procedures | MeDRA Version 23.1 | Systematic Assessment |
| |
| TRANSURETHRAL PROSTATECTOMY | Surgical and medical procedures | MeDRA Version 23.1 | Systematic Assessment |
| |
| ARTERIAL STENOSIS | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ARTERITIS | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HAEMODYNAMIC INSTABILITY | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| SUPERIOR VENA CAVA SYNDROME | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MeDRA Version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| FATIGUE | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| MALAISE | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PYREXIA | General disorders | MeDRA Version 23.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MeDRA Version 23.1 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| NEUTROPHIL COUNT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| PLATELET COUNT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MeDRA Version 23.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MeDRA Version 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| NEUROPATHY PERIPHERAL | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MeDRA Version 23.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MeDRA Version 23.1 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MeDRA Version 23.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MeDRA Version 23.1 | 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 | Jan 11, 2018 | Sep 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000906 | Antibodies |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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 |
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
| OG001 | Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab and carboplatin were administered on Day 1 of each 21-day cycle. Nab-Paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
|
|
|
|
| OG002 | Arm A: Atezolizumab + Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; atezolizumab, paclitaxel, and carboplatin were administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration was as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experienced no further clinical benefit at any time during the induction phase discontinued all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants began maintenance therapy with atezolizumab. Atezolizumab was continued as long as there was clinical benefit to the participant. |
|
|
|
|
|
|
|
|
|
|
|
| OG002 | Arm C: Nab-Paclitaxel + Carboplatin | The induction phase of the study consisted of four or six cycles; carboplatin was administered on Day 1 of each 21-day cycle, nab-paclitaxel was administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration was as follows: nab-paclitaxel, then carboplatin. Participants who experienced disease progression at any time during the induction phase discontinued all study treatment. In the maintenance phase, participants received best supportive care. |
|
|