Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-03-03 @ 6:32 AM
Study NCT ID:
NCT02684006
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2016-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609138', 'term': 'avelumab'}, {'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Avelumab + Axitinib', 'description': '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.', 'otherNumAtRisk': 434, 'deathsNumAtRisk': 442, 'otherNumAffected': 429, 'seriousNumAtRisk': 434, 'deathsNumAffected': 284, 'seriousNumAffected': 231}, {'id': 'EG001', 'title': 'Sunitinib', 'description': '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.', 'otherNumAtRisk': 439, 'deathsNumAtRisk': 444, 'otherNumAffected': 433, 'seriousNumAtRisk': 439, 'deathsNumAffected': 296, 'seriousNumAffected': 166}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 90}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 89}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 89}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 303}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 228}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 185}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 113}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 194}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 50}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 59}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood corticotrophin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 37}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Eastern Cooperative Oncology Group performance status worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 46}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 144}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 83}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 80}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 63}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 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'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Superficial siderosis of central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pulmonary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Exfoliative rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Scar pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Splinter haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Arterial insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 434, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '9.7'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.475', 'ciUpperLimit': '0.790', 'pValueComment': '2-sided p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.\n\nPD 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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) in PD-L1 Positive Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '51.7'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '44.2'}]}]}], 'analyses': [{'pValue': '0.1509', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.701', 'ciUpperLimit': '1.057', 'pValueComment': '2-sided p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '11.1'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.563', 'ciUpperLimit': '0.840', 'pValueComment': '2-sided p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'OS in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '51.1'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '45.2'}]}]}], 'analyses': [{'pValue': '0.1338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.749', 'ciUpperLimit': '1.039', 'pValueComment': '2-sided p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '56.1'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '30.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '64.3'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '27.7', 'upperLimit': '36.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '86.2'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '77.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '88.3'}, {'value': '76.4', 'groupId': 'OG001', 'lowerLimit': '72.1', 'upperLimit': '80.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '13.8'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '34.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '65.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '22.3'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '16.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '16.6'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '9.7'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.565', 'ciUpperLimit': '0.768', 'pValueComment': '2-sided p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '34.6'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '22.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.551', 'ciUpperLimit': '0.754', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Grade Shift in Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Anemia (Baseline G0 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Anemia (Baseline G1 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Anemia (Baseline G2 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Anemia (Baseline G3 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes count decreased (Baseline G0 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes count decreased (Baseline G1 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes count decreased (Baseline G2 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes count decreased (Baseline G3 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils count decreased (Baseline G0 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils count decreased (Baseline G1 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils count decreased (Baseline G2 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets count decreased (Baseline G0 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Platelets count decreased (Baseline G1 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'WBC decreased (Baseline G0 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'WBC decreased (Baseline G1 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'WBC decreased (Baseline G2 to post-baseline G3-4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Grade Shift in Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'ALT increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'ALT increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALP increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALP increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'ALP increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALP increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AST increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'AST increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'AST increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood bilirubin increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Blood bilirubin increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol high (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol high (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol high (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CPK increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'CPK increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CPK increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CPK increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'GGT increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'GGT increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'GGT increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'GGT increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'GGT increased (Baseline G4 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypercalcemia (Baseline G4 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia (Baseline G4 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypermagnesemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Hypermagnesemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hypertriglyceridemia (Baseline G4 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbunemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbunemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbunemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypoalbunemia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypocalcemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (Baseline G4 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serum amylase increased (Baseline G0 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum amylase increased (Baseline G1 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum amylase increased (Baseline G2 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum amylase increased (Baseline G3 to post-baseline G3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Baseline: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.5', 'spread': '13.52', 'groupId': 'OG000'}, {'value': '126.3', 'spread': '12.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '12.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '16.43', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '12.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 4, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '15.95', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '13.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '15.42', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '12.26', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 6, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '15.39', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7, Day 1: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '15.39', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '13.56', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment: Sitting SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '17.40', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '15.67', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.7', 'spread': '9.32', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '8.60', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '9.64', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 4, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '11.61', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '9.30', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '9.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 6, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '9.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7, Day 1: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '11.04', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '9.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment: Sitting DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '12.70', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '10.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '12.49', 'groupId': 'OG000'}, {'value': '75.6', 'spread': '12.63', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '10.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 3, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '11.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 4, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '10.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 5, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '10.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 6, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '12.37', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '10.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Cycle 7, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '11.69', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '10.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '15.29', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '12.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Treatment Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000', 'lowerLimit': '17.41'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '12.82'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)', 'description': 'Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Discontinuation/Failure Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '12.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration (Ctrough) of Avelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}], 'classes': [{'title': 'Cycle 1 (day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.218', 'spread': '1232', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 (day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.69', 'spread': '102', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 (day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.99', 'spread': '96', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 (day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.87', 'spread': '92', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 (day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.62', 'spread': '113', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 (day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.04', 'spread': '98', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 (day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.13', 'spread': '82', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 (day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.15', 'spread': '98', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 (day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.38', 'spread': '86', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 (day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.11', 'spread': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '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', 'description': 'Predose concentration during multiple dosing.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Axitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}], 'classes': [{'title': 'Cycle1 (day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.904', 'spread': '172', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1 (day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.272', 'spread': '174', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)', 'description': 'Predose concentration during multiple dosing.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Axitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}], 'classes': [{'title': 'Cycle1 (day 1); Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.93', 'spread': '182', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1 (day 15); Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.904', 'spread': '172', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1 (day 15); Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.45', 'spread': '157', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1 (day 29); Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.272', 'spread': '174', 'groupId': 'OG000'}]}]}, {'title': 'Cycle1 (day 29); Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.19', 'spread': '174', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At screening', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'PD-L1 Positive Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '9.7'}]}]}, {'title': 'PD-L1 Negative Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.1', 'comment': 'The upper limit of 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': 'NA'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '17.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'PD-L1 Positive Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '61.2'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '30.9'}]}]}, {'title': 'PD-L1 Negative Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000', 'lowerLimit': '38.2', 'upperLimit': '55.8'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '37.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DC in Biomarker-Positive Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '88.6'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '65.4', 'upperLimit': '76.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment.'}, {'type': 'SECONDARY', 'title': 'TTR in Biomarker-Positive Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '10.1'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'PD-L1 Positive Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': 'NA'}]}]}, {'title': 'PD-L1 Negative Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to insufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}], 'classes': [{'title': 'ADA Positive', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'nAb Positive', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.7'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "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)", 'description': "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.", 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Cycle 2 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.034', 'spread': '0.1743', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.1632', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.1826', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.1804', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.1829', 'groupId': 'OG000'}, {'value': '-0.022', 'spread': '0.1667', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1622', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.1826', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.1787', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.1967', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.1651', 'groupId': 'OG000'}, {'value': '0.008', 'spread': '0.1618', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.1848', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.1731', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.2021', 'groupId': 'OG000'}, {'value': '-0.011', 'spread': '0.1662', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.1935', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.1617', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.1854', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.1642', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.1875', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.1712', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.1777', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.1549', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.1938', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.1600', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.1892', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.1487', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.1757', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.1663', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.1950', 'groupId': 'OG000'}, {'value': '-0.000', 'spread': '0.1675', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.1667', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '0.1765', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.1959', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.1665', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.1942', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.1538', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.048', 'spread': '0.1902', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.1904', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.1919', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.1561', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 23 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.2021', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.1729', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.1982', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.1618', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1825', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.1678', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 26 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.039', 'spread': '0.1927', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.1471', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 27 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.2233', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.1492', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.039', 'spread': '0.2060', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.1639', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 29 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.2095', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.1601', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 30 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.2244', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.1557', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.2246', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.1508', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 32 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.2095', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1255', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 33 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.051', 'spread': '0.2294', 'groupId': 'OG000'}, {'value': '-0.060', 'spread': '0.3550', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.029', 'spread': '0.1776', 'groupId': 'OG000'}, {'value': '0.038', 'spread': '0.1558', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 35 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.1442', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.1610', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 36 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.1599', 'groupId': 'OG000'}, {'value': '0.030', 'spread': '0.1551', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 37 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.027', 'spread': '0.1507', 'groupId': 'OG000'}, {'value': '0.052', 'spread': '0.1601', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 38 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.1459', 'groupId': 'OG000'}, {'value': '0.057', 'spread': '0.1666', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 39 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.1569', 'groupId': 'OG000'}, {'value': '0.052', 'spread': '0.1386', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 40 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.1484', 'groupId': 'OG000'}, {'value': '0.060', 'spread': '0.1232', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 41 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.1492', 'groupId': 'OG000'}, {'value': '0.056', 'spread': '0.1853', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 42 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.1634', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.1585', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 43 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.031', 'spread': '0.1334', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.2062', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 44 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.1300', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.2114', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 45 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.1442', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.2191', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 46 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.1380', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.2495', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 47 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.1240', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.2335', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 48 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.1566', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.2833', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 49 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.1356', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.1873', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 50 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.1359', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.2507', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 51 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.1304', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.2594', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 52 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.1265', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.2524', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 53 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.084', 'spread': '0.1437', 'groupId': 'OG000'}, {'value': '0.048', 'spread': '0.1308', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 54 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.1425', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.1157', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 55 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.1121', 'groupId': 'OG000'}, {'value': '0.051', 'spread': '0.1060', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 56 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.083', 'spread': '0.1081', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.1796', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 57 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.104', 'spread': '0.1347', 'groupId': 'OG000'}, {'value': '0.031', 'spread': 'NA', 'comment': 'Standard deviation (SD) could not be calculated as only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 58 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.078', 'spread': '0.1408', 'groupId': 'OG000'}, {'value': '0.031', 'spread': 'NA', 'comment': 'SD could not be calculated as only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 59 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.106', 'spread': '0.1053', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 60 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.1167', 'groupId': 'OG000'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.111', 'spread': '0.2464', 'groupId': 'OG000'}, {'value': '-0.069', 'spread': '0.2375', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avelumab + Axitinib', 'description': '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 42 days.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': '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.'}], 'classes': [{'title': 'Cycle 2 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '16.12', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '15.85', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '16.39', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '16.44', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '17.23', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '17.26', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '16.66', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '16.16', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '16.05', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '15.35', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '16.34', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '14.91', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '16.54', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '13.84', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.06', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '13.77', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '15.12', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '14.46', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '15.70', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '14.59', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '14.39', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '14.29', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '15.07', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '13.98', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '14.97', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '13.63', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '15.08', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '14.02', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '15.44', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '12.88', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '15.31', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '13.69', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '15.61', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '13.10', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '15.15', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '12.58', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '16.30', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '13.00', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '16.43', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '12.82', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 23 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '16.90', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '15.16', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '18.70', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '13.45', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '15.28', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '14.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 26 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '17.10', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '13.00', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 27 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '16.59', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '13.43', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '16.08', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '13.84', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 29 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '15.44', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '14.24', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 30 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '15.78', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '14.61', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '15.42', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '14.88', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 32 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '16.35', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '13.57', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 33 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '16.07', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '20.61', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 34 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '15.25', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '15.91', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 35 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '15.61', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 36 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '15.63', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '17.11', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 37 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '14.63', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '15.86', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 38 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '14.58', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '17.58', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 39 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '14.04', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '15.75', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 40 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '15.00', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '18.17', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 41 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '18.37', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 42 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '13.68', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '18.19', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 43 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '11.64', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '20.14', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 44 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '13.38', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '19.77', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 45 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '17.97', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 46 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '13.25', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '19.31', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 47 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '18.07', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 48 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '21.77', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 49 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '21.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 50 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '13.07', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '20.53', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 51 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '12.36', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '22.93', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 52 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '19.94', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 53 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '11.43', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '16.22', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 54 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '11.54', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '13.34', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 55 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '11.65', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '17.89', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 56 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '8.08', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '5.66', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 57 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'SD could not be calculated as only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 58 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '8.59', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': 'NA', 'comment': 'SD could not be calculated as only 1 participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 59 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.35', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 60 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '16.07', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '19.92', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '19.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': "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.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avelumab + Axitinib', 'description': '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.'}, {'id': 'FG001', 'title': 'Sunitinib', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '444'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}, {'groupId': 'FG001', 'numSubjects': '444'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No longer met eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Global deterioration of health status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '266'}]}, {'type': 'Participation terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'A total of 886 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}, {'value': '444', 'groupId': 'BG001'}, {'value': '886', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Avelumab + Axitinib', 'description': '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.'}, {'id': 'BG001', 'title': 'Sunitinib', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.86', 'spread': '9.95', 'groupId': 'BG000'}, {'value': '60.66', 'spread': '10.28', 'groupId': 'BG001'}, {'value': '60.76', 'spread': '10.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '660', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '765', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-03', 'size': 3054221, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-27T11:51', 'hasProtocol': True}, {'date': '2018-07-16', 'size': 14344832, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-27T13:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 886}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2016-01-25', 'resultsFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-07', 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants', 'timeFrame': '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)', 'description': '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.\n\nPD 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.'}, {'measure': 'Overall Survival (OS) in PD-L1 Positive Participants', 'timeFrame': '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)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'OS in Participants Irrespective of PD-L1 Expression', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': 'Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': 'Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': 'Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': 'Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression', 'timeFrame': 'From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': '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', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.'}, {'measure': 'Number of Participants According to Grade Shift in Hematology Parameters', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.'}, {'measure': 'Number of Participants According to Grade Shift in Chemistry Parameters', 'timeFrame': 'From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)', 'description': '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.'}, {'measure': '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', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and EOT Visit', 'timeFrame': '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)', 'description': 'Pulse rate was measured with the participant in the seated position after the participant had been sitting quietly for at least 5 minutes.'}, {'measure': 'Number of Participants Who Discontinued Treatment Due to Toxicity', 'timeFrame': 'From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)', 'description': 'Number of participants who discontinued treatment due to toxicity are reported in this outcome measure.'}, {'measure': 'Time to Treatment Discontinuation/Failure Due to Toxicity', 'timeFrame': 'From first dose of study treatment until discontinuation of study treatment (maximum up to approximately 89 months)', 'description': '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.'}, {'measure': 'Trough Plasma Concentration (Ctrough) of Avelumab', 'timeFrame': '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', 'description': 'Predose concentration during multiple dosing.'}, {'measure': 'Ctrough of Axitinib', 'timeFrame': 'Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)', 'description': 'Predose concentration during multiple dosing.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Axitinib', 'timeFrame': '2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1'}, {'measure': 'Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue', 'timeFrame': 'At screening', 'description': '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.'}, {'measure': 'PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'timeFrame': 'From date of randomization until PD (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'Percentage of Participants With DC in Biomarker-Positive Subgroup', 'timeFrame': 'From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'TTR in Biomarker-Positive Subgroup', 'timeFrame': 'From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)', 'description': '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.'}, {'measure': 'DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib', 'timeFrame': 'From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)'}, {'measure': 'Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)', 'timeFrame': "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)", 'description': "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."}, {'measure': 'Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score', 'timeFrame': '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)', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'renal cell cancer', 'kidney disease', 'kidney neoplasms', 'axitinib, sunitinib'], 'conditions': ['Renal Cell Cancer']}, 'referencesModule': {'references': [{'pmid': '39886142', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37852850', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37526095', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37146227', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37104931', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35239416', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35166465', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33947608', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33901870', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32895571', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32339648', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30779531', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B9991003', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component\n* Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable\n* Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable\n* At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate bone marrow function, renal and liver functions\n\nExclusion Criteria:\n\n* Prior systemic therapy directed at advanced or metastatic RCC\n* Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.\n* Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways\n* Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors\n* Newly diagnosed or active brain metastasis\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)\n* Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack\n* Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism\n* Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)'}, 'identificationModule': {'nctId': 'NCT02684006', 'briefTitle': 'A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA', 'orgStudyIdInfo': {'id': 'B9991003'}, 'secondaryIdInfos': [{'id': '2015-002429-20', 'type': 'EUDRACT_NUMBER'}, {'id': 'JAVELIN RENAL 101', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avelumab in combination with axitinib', 'description': 'Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.', 'interventionNames': ['Drug: Avelumab (MSB0010718C)', 'Drug: Axitinib (AG-013736)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sunitinib', 'description': 'Sunitinib given at 50 mg PO QD on schedule 4/2', 'interventionNames': ['Drug: Sunitinib']}], 'interventions': [{'name': 'Avelumab (MSB0010718C)', 'type': 'DRUG', 'description': 'IV treatment Avelumab administered at 10 mg/kg IV every two weeks', 'armGroupLabels': ['Avelumab in combination with axitinib']}, {'name': 'Axitinib (AG-013736)', 'type': 'DRUG', 'otherNames': ['Inlyta'], 'description': 'Oral treatment Axitinib given 5 mg PO BID', 'armGroupLabels': ['Avelumab in combination with axitinib']}, {'name': 'Sunitinib', 'type': 'DRUG', 'otherNames': ['Sutent'], 'description': 'Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2', 'armGroupLabels': ['Sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Hematology Oncology Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles General Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC IDS Pharmacy', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Advanced Health Sciences Pavilion', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 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