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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002429-20 | EudraCT Number | ||
| JAVELIN RENAL 101 | Other Identifier | Alias Study Number |
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This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avelumab in combination with axitinib | Experimental | Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID. |
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| Sunitinib | Active Comparator | Sunitinib given at 50 mg PO QD on schedule 4/2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab (MSB0010718C) | Drug | IV treatment Avelumab administered at 10 mg/kg IV every two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version [v] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
| Overall Survival (OS) in PD-L1 Positive Participants | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center | Daphne | Alabama | 36526 | United States | ||
| Southern Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39886142 | Derived | Tucker M, Chen YW, Voss MH, McGregor BA, Bilen MA, Grimm MO, Nathan P, Kollmannsberger C, Tomita Y, Huang B, Amezquita R, Mariani M, di Pietro A, Rini B. Association between neutrophil-to-eosinophil ratio and efficacy outcomes with avelumab plus axitinib or sunitinib in patients with advanced renal cell carcinoma: post hoc analyses from the JAVELIN Renal 101 trial. BMJ Oncol. 2024 Jun 12;3(1):e000181. doi: 10.1136/bmjonc-2023-000181. eCollection 2024. | |
| 39706335 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 886 participants were enrolled and randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab + Axitinib | Participants with advanced renal cell carcinoma (aRCC) received avelumab 10 milligram per kilogram (mg/kg), intravenously (IV) once every two weeks (Q2W) in a 6-week cycle plus axitinib 5 mg, orally twice daily (BID). Each treatment cycle was of 42 days. |
| FG001 | Sunitinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2020 | Aug 27, 2024 |
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| Axitinib (AG-013736) | Drug | Oral treatment Axitinib given 5 mg PO BID |
|
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| Sunitinib | Drug | Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2 |
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| From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
| OS in Participants Irrespective of PD-L1 Expression | OS was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months) |
| Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | OR was defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method. | From date of randomization until PD (maximum up to approximately 26 months) |
| Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression | OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by investigator recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method. | From date of randomization until PD (maximum up to approximately 89 months) |
| Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression | DC was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) according to RECIST v1.1 as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | From date of randomization until PD (maximum up to approximately 26 months) |
| Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression | DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | From date of randomization until PD (maximum up to approximately 89 months) |
| Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by BICR (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) |
| TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by investigator (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months) |
| Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | BICR assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression assessed by BICR or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months) |
| DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | Investigator assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression (PD) assessed by investigator or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months) |
| PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | Investigator assessed PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months) |
| Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression | PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months) |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period (time from the first dose of study treatment through 90 days after last dose of study treatment or start day of new anti-cancer drug therapy-1 day). As per NCI-CTCAE v4.03, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
| Number of Participants According to Grade Shift in Hematology Parameters | Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported. | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
| Number of Participants According to Grade Shift in Chemistry Parameters | Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported. | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
| Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. | Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days) |
| Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit | Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. | Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days) |
| Number of Participants Who Discontinued Treatment Due to Toxicity | Number of participants who discontinued treatment due to toxicity are reported in this outcome measure. | From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months) |
| Time to Treatment Discontinuation/Failure Due to Toxicity | Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity. | From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months) |
| Trough Plasma Concentration (Ctrough) of Avelumab | Predose concentration during multiple dosing. | Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6 |
| Ctrough of Axitinib | Predose concentration during multiple dosing. | Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks) |
| Maximum Plasma Concentration (Cmax) of Axitinib | 2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1 |
| Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue | Tumor biospecimens from pre-treatment tissue samples were analyzed by immunohistochemistry for PD-L1 biomarker expression. Number of participants with positive PD-L1 biomarker expression are reported in this outcome measure. | At screening |
| PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
| Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | From date of randomization until PD (maximum up to approximately 26 months) |
| Percentage of Participants With DC in Biomarker-Positive Subgroup | DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months) |
| TTR in Biomarker-Positive Subgroup | TTR was defined as the time from randomization to the first documentation of objective tumor response (CR or PR) according to RECIST v1.1 which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) |
| DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause, whichever occurred first. As per RECIST version 1.1, CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30%< in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: defined as at least a 20% > in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered progression. | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months) |
| Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib | From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months) |
| Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) | TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms. | Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months) |
| Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score | EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status. | Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months) |
| Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score | EQ-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated better health status. | Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months) |
| Mobile |
| Alabama |
| 36607 |
| United States |
| Southern Cancer Center | Mobile | Alabama | 36608 | United States |
| Tower Hematology Oncology Medical Group | Beverly Hills | California | 90211 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| City of Hope | Duarte | California | 91010 | United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
| USC IDS Pharmacy | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Advanced Health Sciences Pavilion | Los Angeles | California | 90048 | United States |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | United States |
| Cedars-Sinai | Los Angeles | California | 90048 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| University of Colorado Cancer Center Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Clinical Trials Office (CTO) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Investigational Drug Service- Emory University | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| East Jefferson Hematology-Oncology Metairie Physician Service Inc. | Metairie | Louisiana | 70006 | United States |
| New England Cancer Specialists | Kennebunk | Maine | 04043 | United States |
| New England Cancer Specialists | Scarborough | Maine | 04074 | United States |
| New England Cancer Specialists | Topsham | Maine | 04086 | United States |
| Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | United States |
| Massachusetts General Hospital Clinical Trials Pharmacy | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
| Beth Israel Deaconess Medical Center Pharmacy - BIDMC | Boston | Massachusetts | 02215 | United States |
| Dana - Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Baystate Franklin Medical Center | Greenfield | Massachusetts | 01301 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters | City of Saint Peters | Missouri | 63376 | United States |
| Barnes-Jewish Hospital, Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | United States |
| Barnes-Jewish Hospital, Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Washington University Infusion Center Pharmacy | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Barnes-Jewish Hospital, Siteman Cancer Center - South County | St Louis | Missouri | 63129 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana | Billings | Montana | 59102 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 75063 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| New York Oncology Hematology, PC | Albany | New York | 12208 | United States |
| New York Oncology Hematology, P.C. | Clifton Park | New York | 12065 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| NYU Investigational Pharmacy | New York | New York | 10016 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| MSKCC-Monitoring Suite | New York | New York | 10017 | United States |
| Evelyn H. Lauder Breast and Imaging Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Sidney Kimmel Center for Prostate and Urologic Cancers | New York | New York | 10065 | United States |
| Stony Brook University-Cancer Center | Stony Brook | New York | 11794 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | United States |
| The Ohio State University - GU Clinic | Columbus | Ohio | 43210 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Cancer Care Associates Medical Oncology | Allentown | Pennsylvania | 18104 | United States |
| St.Luke's Hospital-Allentown Campus | Allentown | Pennsylvania | 18104 | United States |
| Cancer Care Associate Medical Oncology | Bethlehem | Pennsylvania | 18015 | United States |
| St. Lukes University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| St.Luke's Cancer Center Anderson | Easton | Pennsylvania | 18045 | United States |
| St.Luke's Hospital-Anderson Campus | Easton | Pennsylvania | 18045 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Drug Service, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| St.Luke's Quakertown Hospital | Quakertown | Pennsylvania | 18951 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Gulf Coast | Houston | Texas | 77024 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Investigational Product Center (IPC) | Irving | Texas | 75063 | United States |
| Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| Investigational Products Center (lPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Rainier Hematology-Oncology, PC | Puyallup | Washington | 98373 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Macquarie University Hospital Pharmacy | Macquarie University | New South Wales | 2109 | Australia |
| Macquarie University | Macquarie University | New South Wales | 2109 | Australia |
| Nuclear Medicine Department | Randwick | New South Wales | 2031 | Australia |
| Pharmacy Department, Clinical Trials | Randwick | New South Wales | 2031 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Spectrum Medical Imaging | Randwick | New South Wales | 2031 | Australia |
| Division of Cancer Services | Woolloongabba | Queensland | 4102 | Australia |
| BHS Diagnostic Services | Ballarat | Victoria | 3350 | Australia |
| Lake Imaging | Ballarat | Victoria | 3350 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Eastern Health | Box Hill | Victoria | 3128 | Australia |
| Monash Health Translational Precinct, Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Monash Cancer Centre | East Bentleigh | Victoria | 3165 | Australia |
| Moorabbin Radiology | East Bentleigh | Victoria | 3165 | Australia |
| Slade Health | Mount Waverley | Victoria | 3149 | Australia |
| Ballarat Day Procedure Centre | Wendouree | Victoria | 3355 | Australia |
| Ballarat Oncology & Haematology Services | Wendouree | Victoria | 3355 | Australia |
| Nova Pharmacy | Wendouree | Victoria | 3355 | Australia |
| SKG Radiology | Murdoch | Western Australia | 6050 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| SKG Radiology | Murdoch | Western Australia | 6150 | Australia |
| St John of God Murdoch Hospital | Murdoch | Western Australia | 6150 | Australia |
| EPIC Pharmacy Murdoch | Perth | Western Australia | 6150 | Australia |
| Krankenhaus der Barmherzigen Schwestern Wien | Vienna | 1060 | Austria |
| Medizinische Universitaet Wien | Vienna | 1090 | Austria |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Alberta Health Services - Cancer Care, Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| BC Cancer GU Clinic - Fairmont Medical Building | Vancouver | British Columbia | V5Z IH7 | Canada |
| London Regional Cancer Program, London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| London Regional Cancer Program, London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Herlev Hospital, Onkologisk Afdeling R | Herlev | 2730 | Denmark |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| Centre Eugene Marquis Service Pharmacie - Essais Cliniques | Rennes | Cedex | 35042 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo | Le Mans | 72000 | France |
| Clinique Victor Hugo Centre de Cancerologie de la Sarthe | Le Mans | 72000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Institut de Cancérologie de l'Ouest - Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancerologie de Lorraine (ICL) | Vandœuvre-lès-Nancy | 54519 | France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 072076 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitaetsklinikum Jena | Jena | Thuringia | 07743 | Germany |
| Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie | Jena | Thuringia | 07747 | Germany |
| Universitaetsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely | Budapest | 1097 | Hungary |
| Országos Onkológiai Intézet | Budapest | 1122 | Hungary |
| The Chaim Sheba Medical Center | Tel Litwinsky | Ramat - GAN | 5265601 | Israel |
| Assaf Harofe MC | Beer Yaakov | 70300 | Israel |
| Shamir Medical Center | Beer Yaakov | 70300 | Israel |
| Rambam Health Care Campus | Haifa | 31096 | Israel |
| Rambam Healthcare Campus | Haifa | 31096 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Centro di Riferimento Oncologico - IRCCS | Aviano | (PN) | 33081 | Italy |
| Farmacia Studi Clinici | Rozzano | Milan | 20089 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milan | 20089 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| SC Farmacia | Milan | 20133 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Servizio di Farmacia | Milan | 20141 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | 00152 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| Hirosaki University School of Medicine & Hospital | Hirosaki | Aomori | 036-8563 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaidô | 060-8648 | Japan |
| Iwate Medical University Hospital | Shiwa-gun | Iwate | 028-3695 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Hamamatsu University School of Medicine, University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Akita University Hospital | Akita | 010-8543 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Instituto Nacional de Cancerologia | Mexico City | Mexico City | 14080 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer | Monterrey | Nuevo León | 64460 | Mexico |
| Oaxaca Site Management Organization S.C. | Oaxaca City | 68000 | Mexico |
| Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital | Amsterdam | North Holland | 1066 CX | Netherlands |
| Netherlands Cancer Institute / Apotheek MC Slotervaart | Amsterdam | North Holland | 1066 EC | Netherlands |
| VU University Medical Center (VUmc) | Amsterdam | North Holland | 1081 BT | Netherlands |
| VU University Medical Center (VUmc) | Amsterdam | North Holland | 1081 HZ | Netherlands |
| Sint Franciscus Gasthuis, Pharmacy | Rotterdam | South Holland | 3045 PM | Netherlands |
| Sint Franciscus Gasthuis | Rotterdam | South Holland | 3045 PM | Netherlands |
| Maxima Medisch Centrum | Eindhoven | 5631 BM | Netherlands |
| St Apotheek der Haarlemse Ziekenhuizen | Haarlem | 2035 RC | Netherlands |
| Spaarne Gasthuis | Hoofddorp | 2134 TM | Netherlands |
| Maastricht University Medical Center | Maastricht | 6229 HX | Netherlands |
| Maxima Medisch Centrum | Veldhoven | 5504 DB | Netherlands |
| Maxima Medisch Centrum | Veldhoven | 5504 DL | Netherlands |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Tauranga Hospital, Bay of Plenty Clinical Trials Unit | Tauranga | Bay of Plenty | 3143 | New Zealand |
| Palmerston North Hospital | Palmerston North | Manawatu-Wanganui | 4414 | New Zealand |
| Tauranga Hospital | Tauranga Bay of Plenty | Tauranga | 3112 | New Zealand |
| Wairarapa District Health Board | Masterton | Wairarapa | 5840 | New Zealand |
| Auckland City Hospital Pharmacy | Auckland | 1023 | New Zealand |
| Baxter Healthcare New Zealand | Auckland | 1060 | New Zealand |
| Christchurch Hospital | Christchurch | 8140 | New Zealand |
| Waikato Hospital Pharmacy Services | Hamilton | 3240 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Broadway Radiology | Palmerston North | 4410 | New Zealand |
| "Prof. Dr. Ion Chiricuta" Oncology Institute | Cluj-Napoca | 400015 | Romania |
| S.C. Medisprof S.R.L. | Cluj-Napoca | 400641 | Romania |
| "Sfantul Nectarie" Oncology Center | Craiova | 200347 | Romania |
| Oncomed SRL | Timișoara | 300239 | Romania |
| RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address) | Kursk | Kursk Oblast | 305035 | Russia |
| RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR | Kursk | Kursk Oblast | 305524 | Russia |
| Russian Research Center for Radiology and Surgical Technologies | Saint Petersburg | Pesochny | 197758 | Russia |
| FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF | Saint Petersburg | Poselok Pesochniy | 197758 | Russia |
| Private Medical Institution "Euromedservice" | Pushkin | Sankt-Peterburg | 196603 | Russia |
| Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal | Moscow | 105425 | Russia |
| Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen | Moscow | 125284 | Russia |
| FBIH "Privolzhskiy Regional Medical Center" of FMBA | Nizhny Novgorod | 603001 | Russia |
| SBIH of Nizhegorodskaya region "Clinical-Diagnostics center" | Nizhny Novgorod | 603006 | Russia |
| FBIH "Privolzhskiy Regional Medical Center" of FMBA | Nizhny Novgorod | 603032 | Russia |
| FBIH "Privolzhskiy Regional Medical Center" of FMBA | Nizhny Novgorod | 603109 | Russia |
| SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary" | Nizhny Novgorod | 603126 | Russia |
| Clinical Hospital #122 n.a. L. G. Sokolov | Saint Petersburg | 194291 | Russia |
| NS HI "Road Clinical Hospital of JSC "Russian Railways"" | Saint Petersburg | 195271 | Russia |
| LLC "Diagnostic center "Energo" | Saint Petersburg | 196247 | Russia |
| LLC "Clinical Diagnostic Center "Medex-pert" | Yaroslavl | 150014 | Russia |
| SHI YR Regional Clinical Oncology Hospital | Yaroslavl | 150040 | Russia |
| Clinical Trial Pharmacy, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital, Clinical Pharmacy | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggido | 13620 | South Korea |
| Kyungpook National University Medical Center, Clinical Pharmacy | Daegu | 41404 | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Chungnam National University Hospital, Clinical Pharmacy | Daejeon | 35015 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Seoul National University Hospital, Clinical Pharmacy | Seoul | 03080 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Clinical Trial Pharmacy | Seoul | 05505 | South Korea |
| Samsung Medical Center Clinical Trial Pharmacy | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Sahlgrenska University Hospital, Dept of Oncology | Gothenburg | 413 45 | Sweden |
| Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Mount Vernon Cancer Centre, East & North Herts NHS Trust | London | Middlesex | HA6 2RN | United Kingdom |
| Mount Vernon Cancer Centre, Pharmacy | London | Middlesex | HA6 2RN | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey, London | SM2 5PT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| Addenbrooke's Hospital, Central Pharmacy, Level 1 | Cambridge | CB2 0QQ | United Kingdom |
| Beatson WOSCC | Glasgow | G12 0YN | United Kingdom |
| Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, | Glasgow | G120YN | United Kingdom |
| St Bartholomew's Hospital, Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Clinical Trials Pharmacy, The Christie | Manchester | M20 4BX | United Kingdom |
| Department of Medical Oncology, The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus | Nottingham | NG5 1PB | United Kingdom |
| Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy | Nottingham | NG5 1PB | United Kingdom |
| Derived |
| Choueiri TK, Penkov K, Uemura H, Campbell MT, Pal S, Kollmannsberger C, Lee JL, Venugopal B, van den Eertwegh AJM, Negrier S, Gurney H, Albiges L, Berger R, Haanen JBAG, Oyervides Juarez V, Rini BI, Larkin J, Nole F, Schmidinger M, Atkins MB, Tomita Y, Ellers-Lenz B, Hoffman J, Sandner R, Wang J, di Pietro A, Motzer RJ. Avelumab + axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma: final analysis of the phase III JAVELIN Renal 101 trial. Ann Oncol. 2025 Apr;36(4):387-392. doi: 10.1016/j.annonc.2024.12.008. Epub 2024 Dec 18. |
| 37852850 | Derived | Grimm MO, Oya M, Choueiri TK, Motzer RJ, Schmidinger M, Quinn DI, Gravis-Mescam G, Verzoni E, Van den Eertwegh AJM, di Pietro A, Mariani M, Wang J, Thomaidou D, Albiges L. Impact of Prior Cytoreductive Nephrectomy on Efficacy in Patients with Synchronous Metastatic Renal Cell Carcinoma Treated with Avelumab plus Axitinib or Sunitinib: Post Hoc Analysis from the JAVELIN Renal 101 Phase 3 Trial. Eur Urol. 2024 Jan;85(1):8-12. doi: 10.1016/j.eururo.2023.09.016. Epub 2023 Oct 16. |
| 37526095 | Derived | Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1. |
| 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. |
| 37104931 | Derived | Haanen JBAG, Larkin J, Choueiri TK, Albiges L, Rini BI, Atkins MB, Schmidinger M, Penkov K, Michelon E, Wang J, Mariani M, di Pietro A, Motzer RJ. Extended follow-up from JAVELIN Renal 101: subgroup analysis of avelumab plus axitinib versus sunitinib by the International Metastatic Renal Cell Carcinoma Database Consortium risk group in patients with advanced renal cell carcinoma. ESMO Open. 2023 Jun;8(3):101210. doi: 10.1016/j.esmoop.2023.101210. Epub 2023 Apr 25. |
| 35239416 | Derived | Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3. |
| 35166465 | Derived | Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27. |
| 33947608 | Derived | Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5. |
| 33901870 | Derived | Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. |
| 32895571 | Derived | Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7. |
| 32339648 | Derived | Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25. |
| 30779531 | Derived | Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16. |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab + Axitinib | Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days. |
| BG001 | Sunitinib | Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version [v] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | FAS included all participants who were randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
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| Primary | Overall Survival (OS) in PD-L1 Positive Participants | OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months) |
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| Secondary | PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression | PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
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| Secondary | OS in Participants Irrespective of PD-L1 Expression | OS was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months) |
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| Secondary | Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression | OR was defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method. | FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD (maximum up to approximately 26 months) |
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| Secondary | Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression | OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by investigator recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. 95% CI was based on Clopper-Pearson method. | FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD (maximum up to approximately 89 months) |
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| Secondary | Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression | DC was defined as a best overall response of CR, PR, non-CR/non-PD or stable disease (SD) according to RECIST v1.1 as assessed by BICR. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD (maximum up to approximately 26 months) |
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| Secondary | Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression | DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased by less than 20% from the nadir (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD (maximum up to approximately 89 months) |
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| Secondary | Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by BICR (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) |
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| Secondary | TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | TTR was defined as the time from randomization to the first documentation of objective tumor response according to RECIST v1.1 as assessed by investigator (CR or PR) which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months) |
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| Secondary | Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression | BICR assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression assessed by BICR or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months) |
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| Secondary | DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | Investigator assessed DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of objective tumor progression (PD) assessed by investigator or death due to any cause whichever occurred first. As per RECIST v1.1. CR: complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD: at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months) |
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| Secondary | PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression | Investigator assessed PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months) |
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| Secondary | Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression | PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period (time from the first dose of study treatment through 90 days after last dose of study treatment or start day of new anti-cancer drug therapy-1 day). As per NCI-CTCAE v4.03, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. | Safety analysis set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
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| Secondary | Number of Participants According to Grade Shift in Hematology Parameters | Following hematology parameters were assessed: hemoglobin decreased (anemia), hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell (WBC) decreased. Laboratory abnormalities were graded as per NCI- CTCAE v 4.03 where, grade(G) 0= non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Baseline was defined as last assessment prior to first dose of study treatment. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported in this outcome measure. Only non-zero categories for any reporting arm are reported. | Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
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| Secondary | Number of Participants According to Grade Shift in Chemistry Parameters | Following chemistry parameters were assessed: alanine aminotransferase(ALT) increased, alkaline phosphatase(ALP) increased, aspartate aminotransferase(AST) increased, blood bilirubin increased, cholesterol high, creatinine phosphokinase(CPK) increased, creatinine increased, gamma glutamyl transferase(GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesmia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, lipase increased and serum amylase increased. Laboratory abnormality graded as per NCI CTCAE v4.03; G0=non-missing lab value that does not meet either of G1 through 4 criteria, G1=mild, G2=moderate, G3=severe, G4=life-threatening consequences and G5=death. Number of participants with a baseline grade of 0 to 4 which shifted to G3-4 post-baseline are reported. Only non-zero categories for any reporting arm are reported. | Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months) |
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| Secondary | Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. | Safety analysis set included all participants who received at least one dose of study drug. "Number Analyzed" signifies number of participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days) |
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| Secondary | Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit | Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes. | Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified timepoints. | Posted | Mean | Standard Deviation | beats per minute | Baseline (pre-dose on Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7, EOT visit (maximum up to approximately 89 months) (each cycle=42 days) |
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| Secondary | Number of Participants Who Discontinued Treatment Due to Toxicity | Number of participants who discontinued treatment due to toxicity are reported in this outcome measure. | Safety analysis set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months) |
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| Secondary | Time to Treatment Discontinuation/Failure Due to Toxicity | Time to treatment discontinuation/ failure due to toxicity was defined as the time from first dose of study treatment to discontinuation of study treatment due to an adverse event or death due to study treatment toxicity. | Safety analysis set included all participants who received at least one dose of study drug. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Months | From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months) |
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| Secondary | Trough Plasma Concentration (Ctrough) of Avelumab | Predose concentration during multiple dosing. | Avelumab PK concentration analysis set: all participants who had at least one post-dose concentration above lower limit of quantitation (LLQ) for avelumab. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6 |
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| Secondary | Ctrough of Axitinib | Predose concentration during multiple dosing. | Axitinib PK concentration analysis set: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks) |
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| Secondary | Maximum Plasma Concentration (Cmax) of Axitinib | Axitinib PK concentration analysis: all participants who received at least one dose of study drug and have at least one post-dose concentration above lower limit of quantitation (LLQ) for axitinib. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. This outcome measure was not planned to be analyzed in ''Sunitinib'' reporting group. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1 |
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| Secondary | Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue | Tumor biospecimens from pre-treatment tissue samples were analyzed by immunohistochemistry for PD-L1 biomarker expression. Number of participants with positive PD-L1 biomarker expression are reported in this outcome measure. | Biomarker analysis set for biomarkers that are measured only at screening, included all participants who received at least one dose of study drug and who had at least one screening biomarker assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At screening |
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| Secondary | PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | PFS: time from the date of randomization to the date of the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever occurred first. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute > of at least 5 mm. The appearance of one or more new lesions was also considered progression. | Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months) |
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| Secondary | Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD (maximum up to approximately 26 months) |
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| Secondary | Percentage of Participants With DC in Biomarker-Positive Subgroup | DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds. | Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months) |
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| Secondary | TTR in Biomarker-Positive Subgroup | TTR was defined as the time from randomization to the first documentation of objective tumor response (CR or PR) according to RECIST v1.1 which is subsequently confirmed. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. | Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months) |
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| Secondary | DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups | DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause, whichever occurred first. As per RECIST version 1.1, CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30%< in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: defined as at least a 20% > in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered progression. | Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Median | 95% Confidence Interval | Months | From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months) |
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| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib | Immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA/nAb sample collected for avelumab in "Avelumab + Axitinib" arm. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed for ''Sunitinib'' reporting group. | Posted | Count of Participants | Participants | From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months) |
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| Secondary | Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) | TTD was defined as the time from date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS. FKSI was used to assess symptoms and quality of life (QoL) for those diagnosed with advanced kidney cancer and it consisted of 19 questions. A 9-item subscale of the FKSI known as FKSI-Disease Related Symptoms subscale (FKSI-DRS). This subscale included 9 items: lack of energy, pain, losing weight, bone pain, fatigue, shortness of breath, coughing, bothered by fevers, and hematuria. Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher score indicated greater presence of symptoms. | FAS included all randomized participants. | Posted | Median | Full Range | Months | Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months) |
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| Secondary | Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score | EQ-5D-5L is a 5-item participant-completed questionnaire designed to assess health status in terms of a single utility score. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. Published UK weights were used to create a single summary utility score. Utility scores range from -0.594 to 1, with higher scores representing better health status. | FAS included all randomized participants. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months) |
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| Secondary | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score | EQ-VAS records the participant's self-rated health status from 0 (worst imaginable health status) to 100 (best imaginable health status), where higher scores indicated better health status. | FAS included all randomized participants. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months) |
|
|
From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. For SAEs and non-SAEs safety analysis set was used. For All-cause mortality, FAS was used.
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 | Avelumab + Axitinib | Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days. | 284 | 442 | 231 | 434 | 429 | 434 |
| EG001 | Sunitinib | Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. | 296 | 444 | 166 | 439 | 433 | 439 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myocardial fibrosis | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pituitary apoplexy | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gallbladder rupture | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Actinomycosis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Skin graft infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myocardial necrosis marker increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.0 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Brain hypoxia | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Intracranial tumour haemorrhage | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Irregular sleep wake rhythm disorder | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Superficial siderosis of central nervous system | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA v27.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Splinter haemorrhages | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arterial insufficiency | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Infarction | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v27.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v27.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v27.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2018 | Aug 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009369 | Neoplasms |
| D007674 | Kidney Diseases |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| D000077784 | Axitinib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011758 | Pyrroles |
| D007211 | Indoles |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
| Sunitinib |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
|
|
| Sunitinib |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| Sunitinib |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
| Sunitinib |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Sunitinib |
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. |
|
|
|
|
|
|
|
| Participants |
|
|