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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004684-20 | EudraCT Number |
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This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Bevacizumab | Experimental | Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first. |
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| Sunitinib | Active Comparator | Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Drug | Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 millimeters (mm); >/=1 new lesion(s); and/or unequivocal progression of existing non-TLs. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants Who Died of Any Cause in ITT Population | Percentage of participants who died of any cause was reported. | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Percentage of participants who died of any cause was reported. | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
| OS in PD-L1-Selected Population |
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Inclusion Criteria:
Exclusion Criteria:
Disease-Specific Exclusions:
General Medical Exclusions:
Exclusion Criteria Related to Medications:
Bevacizumab- and Sunitinib-Specific Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | United States | ||
| University of California at Irvine Medical Center; Department of Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37146227 | Derived | Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2. | |
| 34940781 |
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A total of 1228 participants were screened, out of which, 915 participants were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Participants received sunitinib at a dose of 50 milligrams (mg) administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD) as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2018 |
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| Bevacizumab | Drug | Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle. |
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| Sunitinib | Drug | Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle. |
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| Overall Survival (OS) in ITT Population | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. |
| Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
| Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| PFS as Determined by an IRC According to RECIST v1.1 in ITT Population | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population | Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (<) 10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population | Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population | Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population | PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population | Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population | Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology | Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
| Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology | Percentage of participants with sarcomatoid histology who died of any cause was reported. | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
| OS in Participants With Sarcomatoid Histology | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
| Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score | The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point. | Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days |
| Change From Baseline in Symptom Severity as Determined by MDASI Part I Score | The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement. | Baseline; End of Treatment (EoT) visit (up to approximately 27 months) |
| Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score | The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement. | Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days |
| Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item | The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement. | Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days |
| Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score | The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. | Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days |
| Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint. | Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) |
| Number of Participants With ATAs Against Bevacizumab | The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. | Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) |
| Maximum Observed Serum Concentration (Cmax) for Atezolizumab | Cmax for atezolizumab was estimated from plasma concentration versus time data. | 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) |
| Minimum Observed Serum Concentration (Cmin) for Atezolizumab | Cmin for atezolizumab was estimated from plasma concentration versus time data. | Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days |
| Cmax for Bevacizumab | Cmax for bevacizumab was estimated from plasma concentration versus time data. | 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) |
| Cmin for Bevacizumab | Cmin for bevacizumab was estimated from plasma concentration versus time data. | Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days) |
| Orange |
| California |
| 92868 |
| United States |
| University of California | San Francisco | California | 94158 | United States |
| University of Colorado; Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Center; Medical Oncology | Boulder | Colorado | 80303 | United States |
| Georgetown U; Lombardi Comp Can | Washington D.C. | District of Columbia | 20016-1468 | United States |
| Lynn Cancer Institute/Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| Florida Cancer Specialists - Port Charlotte | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York Oncology Hematology,P.C.-Albany | Albany | New York | 12208 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic Foundation; Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Northwest Cancer Specialists, P.C. | Tigard | Oregon | 97223 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Univ Medical Ctr | Nashville | Tennessee | 37232 | United States |
| Texas Oncology-Baylor Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Oncology and Hematology Associates of SW Virginia-Raonoke | Roanoke | Virginia | 24014 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2109 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Icon Cancer Foundation | South Brisbane | Queensland | 4101 | Australia |
| Ashford Cancer Center Research | Kurralta Park | South Australia | 5037 | Australia |
| Austin Hospital; Medical Oncology | Heidelberg | Victoria | 3084 | Australia |
| St John of God Hospital | Murdoch | Western Australia | 6150 | Australia |
| University Clinical Centre of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| Hospital de Caridade de Ijui; Oncologia | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU de Quebec Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Prague | 128 08 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Aarhus Universitetshospital; Kræftafdelingen | Aarhus N | 8200 | Denmark |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| ICO Paul Papin; Oncologie Medicale. | Angers | 49055 | France |
| Hopital Saint Andre; Oncologie 2 | Bordeaux | 33075 | France |
| Centre Francois Baclesse; Urologie Gynecologie | Caen | 14076 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Institut Paoli Calmettes; Oncologie Medicale | Marseille | 13273 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| APHP - Hospital Saint Louis | Paris | 75475 | France |
| Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale | Paris | 75908 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie | Dresden | 01307 | Germany |
| Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung | Essen | 45122 | Germany |
| Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg | Heidelberg | 69120 | Germany |
| Klinikum d.Universität München Campus Großhadern | München | 81377 | Germany |
| Universitätsklinikum Tübingen; Klinik für Urologie | Tübingen | 72076 | Germany |
| Az. Osp. Cardarelli; Divisione Di Oncologia | Naples | Campania | 80131 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| A.O. Universitaria Policlinico Di Modena; Oncologia | Modena | Emilia-Romagna | 41100 | Italy |
| Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica | Rome | Lazio | 00152 | Italy |
| Irccs Ospedale San Raffaele;Oncologia Medica | Milan | Lombardy | 20132 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| Fondazione IRCCS Policlinico San Matteo, Oncologia | Pavia | Lombardy | 27100 | Italy |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia | Arezzo | Tuscany | 52100 | Italy |
| Nagoya University Hospital; Urology | Aichi | 466-8560 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Gunma University Hospital | Gunma | 371-8511 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| University of Tsukuba Hospital; Urology | Ibaraki | 305-8576 | Japan |
| Yokohama City University Hospital | Kanagawa | 236-0004 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Iwate Medical University Hospital | Numakunai | 028-3695 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute; Urology | Osaka | 541-8567 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8586 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| Tokyo Medical and Dental University Hospital | Tokyo | 113-8519 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| The Cancer Institute Hospital, JFCR; Urology | Tokyo | 135-8550 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University | Tokyo | 162-0054 | Japan |
| Cancerología | Querétaro | 76090 | Mexico |
| Centro Oncologico Estatal ISSEMYM | Toluca | 50180 | Mexico |
| Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli | Lublin | 20-090 | Poland |
| Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna | Poznan | 60-569 | Poland |
| Saint Elizabeth's Hospital | Warsaw | 02-616 | Poland |
| MAGODENT Sp. z o.o. | Warsaw | 04-125 | Poland |
| ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic | Barnaul | Altayskiy Kray | 656049 | Russia |
| GBUZ Nizhegorodskay Region: Clinical Diagnostic Center | Nizhny Novgorod | Niznij Novgorod | 603001 | Russia |
| P.A. Herzen Oncological Inst. ; Oncology | Moscow | 125284 | Russia |
| City Clinical Oncology Hospital | Moscow | 143423 | Russia |
| National University Hospital | Singapore | 117599 | Singapore |
| National Cancer Centre; Medical Oncology | Singapore | 169610 | Singapore |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 003-722 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Oncología | Barcelona | 08036 | Spain |
| Hospital Duran i Reynals; Oncologia | Barcelona | 08907 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Taichung Veterans General Hospital; Division of Urology | Taichung | 407 | Taiwan |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Chang Gung Medical Foundation-Linkou, Urinary Oncology | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital; Medical Oncology | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital; Department of Oncology | Songkhla | 90110 | Thailand |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department | Edirne | 22770 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology | Istanbul | 34300 | Turkey (Türkiye) |
| Clatterbridge Cancer Centre | Bebington | CH63 4JY | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Royal Blackburn Hospital | Blackburn | BB2 3HH | United Kingdom |
| Addenbrookes Nhs Trust; Oncology Clinical Trials Unit | Cambridge | CB2 0QQ | United Kingdom |
| Barts Health NHS Trust - St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Royal Free Hospital; Dept of Oncology | London | NW3 2QG | United Kingdom |
| Christie Hospital Nhs Trust; Medical Oncology | Manchester | M2O 4BX | United Kingdom |
| Churchill Hospital; Oxford Cancer and Haematology Centre | Oxford | OX3 7LJ | United Kingdom |
| Southampton General Hospital; Medical Oncology | Southampton | SO16 6YD | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| Singleton Hospital; Pharmacy Department | Swansea | SA2 8QA | United Kingdom |
| Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981. |
| 32127394 | Derived | Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grullich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naive Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3. |
| 31079938 | Derived | Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9. |
| FG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 milligrams per kilogram (mg/kg) administered via intravenous (IV) infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on the intent-to-treat (ITT) population, which included all randomized participants whether or not the assigned study treatment was received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
| BG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population | Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 millimeters (mm); >/=1 new lesion(s); and/or unequivocal progression of existing non-TLs. | Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization. | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Primary | Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the PD-L1-Selected Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Primary | Percentage of Participants Who Died of Any Cause in ITT Population | Percentage of participants who died of any cause was reported. | Analysis was performed on the ITT Population. | Posted | Number | percentage of participants | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Primary | Overall Survival (OS) in ITT Population | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population. | Posted | Median | 95% Confidence Interval | months | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Secondary | Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population | Percentage of participants who died of any cause was reported. | Analysis was performed on the PD-L1-Selected Population. | Posted | Number | percentage of participants | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Secondary | OS in PD-L1-Selected Population | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the PD-L1-Selected Population. | Posted | Median | 95% Confidence Interval | months | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Secondary | Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Analysis was performed on the ITT Population. | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | PFS as Determined by an IRC According to RECIST v1.1 in ITT Population | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population | Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Analysis was performed on the PD-L1-Selected Population. | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population | PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the PD-L1-Selected Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population | Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (<) 10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Analysis was performed on the ORR-Evaluable Population, which included all participants in the ITT population with measurable disease at baseline, as determined by the investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Analysis was performed on DOR-Evaluable Population, which included all participants with a CR/PR in the ORR-Evaluable Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population | Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Analysis was performed on the ORR-Evaluable Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Analysis was performed on the DOR-Evaluable Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population | Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. | Analysis was performed on the ITT Population. | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population | PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population | Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders. | Analysis was performed on the ORR-Evaluable Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population | DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley. | Analysis was performed on DOR-Evaluable Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population | Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Analysis was performed on the ITT Population. | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology | Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. | Analysis was performed on the ITT Population participants with sarcomatoid histology (defined by investigator-assessed conventional histopathology). | Posted | Number | percentage of participants | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology | PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population participants with sarcomatoid histology. | Posted | Median | 95% Confidence Interval | months | Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months) |
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| Secondary | Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology | Percentage of participants with sarcomatoid histology who died of any cause was reported. | Analysis was performed on the ITT Population participants with sarcomatoid histology. | Posted | Number | percentage of participants | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Secondary | OS in Participants With Sarcomatoid Histology | OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. | Analysis was performed on the ITT Population participants with sarcomatoid histology. | Posted | Median | 95% Confidence Interval | months | Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months) |
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| Secondary | Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score | The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point. | Analysis was performed on the patient-reported outcome (PRO)-Evaluable Population, which included all participants with a non-missing baseline PRO assessment and >/=1 post-baseline PRO assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days |
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| Secondary | Change From Baseline in Symptom Severity as Determined by MDASI Part I Score | The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement. | Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline; End of Treatment (EoT) visit (up to approximately 27 months) |
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| Secondary | Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score | The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement. | Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days |
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| Secondary | Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item | The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement. | Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days |
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| Secondary | Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score | The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. | Analysis was performed on the PRO-Evaluable Population. Here, 'Number Analyzed' = number of participants evaluable at specified time point. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days |
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| Secondary | Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab | The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint. | Analysis was performed on the ATA-Evaluable Population, which included all participants in the Atezolizumab + Bevacizumab arm with a non-missing baseline ATA sample and >/=1 post-baseline ATA sample. | Posted | Number | participants | Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) |
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| Secondary | Number of Participants With ATAs Against Bevacizumab | The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. | Analysis was performed on the ATA-Evaluable Population. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint. | Posted | Number | participants | Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for Atezolizumab | Cmax for atezolizumab was estimated from plasma concentration versus time data. | Analysis was performed on the Atezolizumab Pharmacokinetic (PK) Population, which included all participants who received atezolizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) |
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| Secondary | Minimum Observed Serum Concentration (Cmin) for Atezolizumab | Cmin for atezolizumab was estimated from plasma concentration versus time data. | Analysis was performed on the Atezolizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point. | Posted | Mean | Standard Deviation | mcg/mL | Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days |
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| Secondary | Cmax for Bevacizumab | Cmax for bevacizumab was estimated from plasma concentration versus time data. | Analysis was performed on the Bevacizumab PK Population, which included all participants who received bevacizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | 30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days) |
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| Secondary | Cmin for Bevacizumab | Cmin for bevacizumab was estimated from plasma concentration versus time data. | Analysis was performed on the Bevacizumab PK Population. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days) |
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Baseline up to data cut-off date 13 December 2021 (overall approximately 79 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious and other adverse events reported based on safety population, which included participants who received any amount of any study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Participants received sunitinib at a dose of 50 mg administered orally via capsules once daily on Days 1 to 28 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. | 270 | 461 | 169 | 446 | 435 | 446 |
| EG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. | 263 | 454 | 191 | 451 | 437 | 451 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| FACTOR VIII INHIBITION | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CORONARY ARTERY INSUFFICIENCY | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MYOCARDITIS | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GLUCOCORTICOID DEFICIENCY | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HYPOPHYSITIS | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ANAL FISTULA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| AUTOIMMUNE COLITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DUODENAL OBSTRUCTION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DUODENAL ULCER | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GASTROINTESTINAL FISTULA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| IMMUNE-MEDIATED ENTEROCOLITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MECHANICAL ILEUS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| OESOPHAGEAL PERFORATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SMALL INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SUBILEUS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| INFUSION SITE EXTRAVASATION | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MUCOSAL INFLAMMATION | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PERIPHERAL SWELLING | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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| AUTOIMMUNE HEPATITIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HEPATITIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| IMMUNE-MEDIATED HEPATITIS | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| JAUNDICE | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| LIVER INJURY | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
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| CYTOKINE RELEASE SYNDROME | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SYSTEMIC IMMUNE ACTIVATION | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| ABSCESS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| APPENDICITIS PERFORATED | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
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| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| COMPLICATED APPENDICITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| ENCEPHALITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMATOMA INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| LUNG ABSCESS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| MENINGITIS ASEPTIC | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PARONYCHIA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PILONIDAL CYST | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMONIA MYCOPLASMAL | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PYELONEPHRITIS CHRONIC | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| SCROTAL ABSCESS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| ACCIDENT AT HOME | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| CONJUNCTIVAL LACERATION | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| GASTROINTESTINAL ANASTOMOTIC LEAK | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| NECK INJURY | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| TOOTH INJURY | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| BLOOD SODIUM DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMATOMA MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MYOSITIS | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SACRAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CHOLANGIOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| COLON NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| GALLBLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| GASTRIC CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| INTRACRANIAL TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| GLIOSIS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| LUMBOSACRAL PLEXOPATHY | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PARAPLEGIA | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| THALAMUS HAEMORRHAGE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DEVICE DISLOCATION | Product Issues | MedDRA Version 24.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEPHRITIS | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| UROGENITAL HAEMORRHAGE | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| LARYNGEAL OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PULMONARY INFARCTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| TOXIC EPIDERMAL NECROLYSIS | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HERNIA REPAIR | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
| |
| ANEURYSM | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| AORTIC DISORDER | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| AORTIC DISSECTION | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANEURYSM | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SHOCK | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| VASCULITIS | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HAIR COLOUR CHANGES | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| YELLOW SKIN | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
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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 |
| Aug 21, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 |
| Atezolizumab + Bevacizumab |
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
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| Counts |
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| Participants |
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| OG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
| OG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
| OG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
|
|
|
|
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|
|
| OG001 |
| Atezolizumab + Bevacizumab |
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
|
| Atezolizumab + Bevacizumab |
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
|
|
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| OG001 | Atezolizumab + Bevacizumab | Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
| Atezolizumab + Bevacizumab |
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
|
| OG001 |
| Atezolizumab + Bevacizumab |
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first. |
|
|
Participants received atezolizumab at a dose of 1200 mg and bevacizumab at a dose of 15 mg/kg administered via IV infusions on Day 1 and Day 22 of each 42-day cycle until loss of clinical benefit in the opinion of the investigator, unacceptable toxicity or symptomatic deterioration attributed to PD as determined by the investigator, withdrawal of consent, or death, whichever occurred first.
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