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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000177-69 | EudraCT Number |
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This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.
Eligible participants will be categorized in to three groups as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab (MPDL3280): 1L Participants | Experimental | Participants with no prior chemotherapy for advanced NSCLC disease will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. |
|
| Atezolizumab (MPDL3280): 2L+ Participants | Experimental | Participants who progress during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
| Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants | Experimental | Participants with previously treated brain metastases and who progress during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, will receive atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody | Drug | Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders. | Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1) | Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. Hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of NSCLC discontinued greater than 7 days prior to Cycle 1 Day 1
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
Known central nervous system disease, including treated brain metastases in the following participants:
Participants with a history of treated asymptomatic brain metastases are allowed in the 2L+ participants and previously treated for brain metastases.
Leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute - Pima Center | Scottsdale | Arizona | 85258 | United States | ||
| Stanford University/Lucile Packard Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33241650 | Derived | Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685. |
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Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab (MPDL3280) : 1L Participants | Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. |
| FG001 | Atezolizumab (MPDL3280): 2L+ Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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| Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
| Duration of Objective Response According to RECIST v1.1 | Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment. | Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
| Percentage of Participants With 6-Month Duration of Objective Response | Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment. | Month 6 |
| Percentage of Participants With Disease Progression or Death According to RECIST v1.1 | For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
| Progression-Free Survival (PFS) According to RECIST v1.1 | PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day. | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
| Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1 | Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Months 6, 12 and 30 |
| Percentage of Participants With Disease Progression or Death According to Modified RECIST | For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
| PFS According to Modified RECIST | PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
| Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST | Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. | Months 6, 12 and 30 |
| Percentage of Participants With Death | Participants were followed for survival throughout the study. | Baseline till death or up to 20 months, whichever occurred first |
| Overall Survival (OS) | OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day. | Baseline till death or up to 20 months, whichever occurred first |
| Maximum Plasma Concentration (Cmax) for Atezolizumab | Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1 |
| Minimum Plasma Concentration (Cmin) for Atezolizumab | Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16 |
| Palo Alto |
| California |
| 94304 |
| United States |
| The Angeles Clinic and Research Institute, Santa Monica Office | Santa Monica | California | 90025 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Florida Hospital Cancer Inst | Orlando | Florida | 32804 | United States |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Florida Cancer Specialists. | St. Petersburg | Florida | 33705 | United States |
| H. Lee Moffitt Cancer Center and Research Inst. | Tampa | Florida | 33612 | United States |
| Northwest Georgia Oncology Centers P.C. | Carrollton | Georgia | 30117 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Health Systems | Durham | North Carolina | 27710 | United States |
| Carolina BioOncology Institute; Can Therapy & Res Ctr | Huntersville | North Carolina | 28078 | United States |
| Ohio State Uni Hospital | Columbus | Ohio | 43210-1250 | United States |
| Oncology Hematology Care, Inc. | Hamilton | Ohio | 45103 | United States |
| Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology | Hershey | Pennsylvania | 17033 | United States |
| Penn Presbyterian Medical Center; Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI-Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Huntsman Cancer Institute; University of Utah | Salt Lake City | Utah | 84112 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| University of Washington Seattle Cancer Care Alliance | Seattle | Washington | 98195 | United States |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Centre Léon Bérard | Lyon | 69008 | France |
| Antoni van Leeuwenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Queen Mary University of London | London | EC1M 6BQ | United Kingdom |
| Royal Marsden Hospital - Fulham; Oncology Department | London | SW3 6JJ | United Kingdom |
| Royal Marsden Hospital - Fulham | London | SW3 6JJ | United Kingdom |
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| FG002 | Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Survival Follow-up |
|
|
All participants who received any dose of atezolizumab during the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab (MPDL3280) : 1L Participants | Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. |
| BG001 | Atezolizumab (MPDL3280) : 2L+ Participants | Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| BG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders. | Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
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| Secondary | Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1) | Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders. | Efficacy-evaluable population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
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| Secondary | Duration of Objective Response According to RECIST v1.1 | Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment. | Efficacy-evaluable population with a confirmed objective response. | Posted | Median | Full Range | months | Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months) |
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| Secondary | Percentage of Participants With 6-Month Duration of Objective Response | Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment. | Efficacy-evaluable population with a confirmed objective response. | Posted | Number | percentage of participants | Month 6 |
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| Secondary | Percentage of Participants With Disease Progression or Death According to RECIST v1.1 | For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Efficacy-evaluable population. | Posted | Number | percentage of participants | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
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| Secondary | Progression-Free Survival (PFS) According to RECIST v1.1 | PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day. | Efficacy-evaluable population. | Posted | Median | Full Range | months | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
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| Secondary | Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1 | Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Efficacy-evaluable population. | Posted | Number | percentage of participants | Months 6, 12 and 30 |
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| Secondary | Percentage of Participants With Disease Progression or Death According to Modified RECIST | For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. | Efficacy-evaluable population. | Posted | Number | percentage of participants | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
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| Secondary | PFS According to Modified RECIST | PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. | Efficacy-evaluable population. | Posted | Median | Full Range | months | Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months) |
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| Secondary | Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST | Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. | Efficacy-evaluable population. | Posted | Number | percentage of participants | Months 6, 12 and 30 |
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| Secondary | Percentage of Participants With Death | Participants were followed for survival throughout the study. | Efficacy-evaluable population. | Posted | Number | percentage of participants | Baseline till death or up to 20 months, whichever occurred first |
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| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day. | Efficacy-evaluable population. | Posted | Median | 95% Confidence Interval | months | Baseline till death or up to 20 months, whichever occurred first |
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| Secondary | Maximum Plasma Concentration (Cmax) for Atezolizumab | Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points. Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1 |
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| Secondary | Minimum Plasma Concentration (Cmin) for Atezolizumab | Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16 |
|
|
Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
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 (MPDL3280A) : 1L Participants | Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. | 17 | 31 | 31 | 31 | ||
| EG001 | Atezolizumab (MPDL3280A) : 2L+ Participants | Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. | 46 | 93 | 88 | 93 | ||
| EG002 | Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. | 6 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Thyroiditis acute | Endocrine disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| AUTOIMMUNE COLITIS | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| INFLUENZA B VIRUS TEST POSITIVE | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Aortic valve thickening | Cardiac disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| EXCESSIVE CERUMEN PRODUCTION | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Deafness bilateral | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Non-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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Other |
|
| Male |
|
| OG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
| OG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
| OG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|
| OG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
|
|
| OG002 | Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants | Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
|
|
|
|
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. |
|
|
|
|