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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000269-30 | EudraCT Number |
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The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | The dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody | Drug | Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-progression Rate (NPR) at 18 Weeks | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | At Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| NPR at 24 Weeks | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. |
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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 |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10027 | United States | ||
| Memorial Sloan Kettering |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35305400 | Derived | Tabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, Jaeger D, Maio M, Mileshkin L, Melero I. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419. doi: 10.1016/j.esmoop.2022.100419. Epub 2022 Mar 16. |
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Participants with advanced solid tumors were eligible to enroll in the study.
Participants were enrolled at 47 sites in 18 countries: Austria, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Russian Federation, Spain, Switzerland, Turkey, United Kingdom and United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab | Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. |
| 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 23, 2019 | Mar 24, 2021 |
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| At Week 24 |
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Percentage of Participants by Best Overall Response (BOR) | BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria. For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for >/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer: CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Duration of Objective Response (DOR) | DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Progression-Free Survival (PFS) | PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Time to Progression (TTP) | Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| Overall Survival (OS) | OS was defined as the time from the first day of study treatment to death from any cause. | Baseline until death due to any cause (up to 4.5 years) |
| Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 4.5 years |
| Treatment Duration of Atezolizumab | Baseline up to approximately 4.5 years |
| Mean Number of Doses of Atezolizumab | Baseline up to approximately 4.5 years |
| Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Baseline up to 4.5 years |
| Serum Concentration of Atezolizumab | Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years |
| Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| ORR Based on Modified RECIST v1.1 | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. ORR was defined as the percentage of participants with CR or PR. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| CBR Based on Modified RECIST v1.1 | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. CBR was defined as the percentage of participants with CR, PR, or SD lasting for >/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| New York |
| New York |
| 10065 |
| United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | 8036 | Austria |
| Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei | Vienna | 1090 | Austria |
| INCA 1- Instituto Nacional de Câncer X | Rio de Janeiro | Rio de Janeiro | 20231-050 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | M5G 2M9 | Canada |
| Aarhus Universitetshospital; Kræftafdelingen | Aarhus N | 8200 | Denmark |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed | Odense C | 5000 | Denmark |
| Helsinki University Central Hospital; Dept of Oncology | Helsinki | 00029 | Finland |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Hopital Saint Louis, Service D Oncologie Medicale | Paris | 75475 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik | Hamburg | 20246 | Germany |
| Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen | Heidelberg | 69120 | Germany |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | 54290 | Germany |
| St Vincent'S Uni Hospital; Medical Oncology | Dublin | 4 | Ireland |
| St James' Hospital; Cancer Clinical Trials Office | Dublin | Ireland |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Tuscany | 53100 | Italy |
| Antoni van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Haukeland Universitetssjukehus; Klinisk forskningspost | Bergen | 5021 | Norway |
| Oslo Universitetssykehus HF; Radiumhospitalet | Oslo | 0310 | Norway |
| Centrum Onkologii w Bydgoszczy | Bydgoszcz | 85-796 | Poland |
| Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdansk | 80-214 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer. | Warsaw | 02-781 | Poland |
| Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy | Moscow | 115478 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | 197758 | Russia |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Freiburger Spital; Onkologie | Fribourg | 1708 | Switzerland |
| Kantonsspital St. Gallen; Onkologie/Hämatologie | Sankt Gallen | 9007 | Switzerland |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Prof. Dr. Cemil Tascioglu City Hospital; Med Onc | Istanbul | 34384 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye/Ankara | 06230 | Turkey (Türkiye) |
| Clatterbridge Cancer Centre | Bebington | CH63 4JY | United Kingdom |
| Southampton General Hospital; Medical Oncology | Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab | Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. |
| Units | Counts |
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| 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Non-progression Rate (NPR) at 18 Weeks | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 18 |
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| Secondary | NPR at 24 Weeks | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 24 |
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| Secondary | Overall Response Rate (ORR) | ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Percentage of Participants by Best Overall Response (BOR) | BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria. For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Clinical Benefit Rate (CBR) | CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for >/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer: CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Duration of Objective Response (DOR) | DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. As pre-specified in the SAP DOR was not analyzed if there were less than 4 participants available for the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Progression-Free Survival (PFS) | PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Median | 95% Confidence Interval | months | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Time to Progression (TTP) | Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Median | 95% Confidence Interval | months | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the first day of study treatment to death from any cause. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Median | 95% Confidence Interval | months | Baseline until death due to any cause (up to 4.5 years) |
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| Secondary | Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 4.5 years |
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| Secondary | Treatment Duration of Atezolizumab | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Median | Full Range | months | Baseline up to approximately 4.5 years |
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| Secondary | Mean Number of Doses of Atezolizumab | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Mean | Standard Deviation | doses | Baseline up to approximately 4.5 years |
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| Secondary | Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Number | percentage of participants | Baseline up to 4.5 years |
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| Secondary | Serum Concentration of Atezolizumab | Safety analysis set included all participants who received at least one dose of study medication. | Posted | Mean | Standard Deviation | ng/mL | Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years |
|
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| Secondary | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
| ||||||||||||||||||||||||||||||
| Secondary | ORR Based on Modified RECIST v1.1 | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. ORR was defined as the percentage of participants with CR or PR. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
|
| ||||||||||||||||||||||||||||
| Secondary | CBR Based on Modified RECIST v1.1 | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented. CBR was defined as the percentage of participants with CR, PR, or SD lasting for >/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. | Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) |
|
Up to approximately 4.5 years
Safety analysis set included all participants who received at least one dose of 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 | Atezolizumab | Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. | 310 | 474 | 142 | 474 | 368 | 474 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| APLASTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| LYMPH NODE HAEMORRHAGE | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SPLENIC VEIN THROMBOSIS | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| IMMUNE-MEDIATED ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATIC VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| BILIARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATITIS E | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PAROTITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TYPE 1 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SACROILIITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| CEREBELLAR ATAXIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIPLEGIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYDROCEPHALUS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| IMMUNE-MEDIATED ENCEPHALITIS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VAGINAL FISTULA | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CHYLOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| TRACHEAL INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NEPHROSTOMY TUBE REMOVAL | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2020 | Mar 24, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000906 | Antibodies |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Black or African American |
|
| Native Hawaiian Other Pacific Island |
|
| White |
|
| Unknown race |
|
| Not Reported In France |
|
| Not Available |
|
| Not reported |
|
| Unknown |
|
|
| Nasopharyngeal Carcinoma |
|
|
| High Microsatellite Instability (MSI-H) or Mismatch Repair (MMR) Deficient Colorectal Cancer |
|
|
| Breast Cancer Type 1/2 Susceptibility Protein (BRCA) Mutated Ovarian Cancer |
|
|
| BRCA Mutated Breast Cancer |
|
|
| Liposarcoma |
|
|
| Leiomyosarcoma |
|
|
| Gastrointestinal Stromal Tumor (GIST) |
|
|
| Undifferentiated Pleomorphic Sarcoma |
|
|
| Known Translocation-Related Sarcomas |
|
|
| Radiation Induced Sarcoma |
|
|
| Osteosarcoma |
|
|
| Chondrosarcoma |
|
|
| Pleural Mesothelioma |
|
|
| Peritoneal Mesothelioma |
|
|
| Cholangiocarcinoma/Cancer of the Biliary Tract |
|
|
| Anaplastic Thyroid Cancer (TC) |
|
|
| Follicular or Papillary Thyroid Cancer (TC) |
|
|
| Medullary/Follicular/Papillary TC |
|
|
| Gastric/Gastro-esophageal (GE) Junction Adenocarcinoma |
|
|
| Malignant Germ Cell Tumors |
|
|
| Estrogen Receptor (ER)+/Human EGF Receptor 2 (HER2)- Hypermutated Metastatic Breast Cancer (MBC) |
|
|
| Thymoma |
|
|
| Thymic cancer |
|
|
| Low/Intermediate Grade Carcinoid |
|
|
| Poorly Differentiated Grade (excluding small cell lung cancer [SCLC]) |
|
|
| Head and Neck Squamous Cell Carcinoma |
|
|
| Penile Cancer |
|
|
| Anal Cancer |
|
|
| Known MSI High or MMR Deficient Tumors |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline ADAs |
|
| ||||
| Treatment-emergent ADAs |
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|