Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-27 @ 6:47 AM
Study NCT ID:
NCT05064059
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C559147', 'term': 'regorafenib'}, {'id': 'C000613803', 'term': 'trifluridine tipiracil drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 38 months', 'description': 'Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \\& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.', 'otherNumAtRisk': 221, 'deathsNumAtRisk': 221, 'otherNumAffected': 193, 'seriousNumAtRisk': 221, 'deathsNumAffected': 202, 'seriousNumAffected': 75}, {'id': 'EG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.", 'otherNumAtRisk': 210, 'deathsNumAtRisk': 220, 'otherNumAffected': 187, 'seriousNumAtRisk': 210, 'deathsNumAffected': 203, 'seriousNumAffected': 56}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 55, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 73, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 44, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 65, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 66, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 35, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 58, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 49, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 37, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 59, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 50, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 51, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': "Addison's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 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increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tumour perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary cavitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune-mediated dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '8.8'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '9.9'}]}]}], 'analyses': [{'pValue': '0.4183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.20', 'pValueComment': 'One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 33 months', 'description': 'OS was defined as the time from randomization to death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '2.1'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '0.9967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.64', 'pValueComment': 'One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 21 months', 'description': 'PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '10.9'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.2'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '2.5', 'ciUpperLimit': '10.1', 'pValueComment': 'One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \\> 0.', 'estimateComment': 'Difference in percentage and 95% CI were based on the Miettinen \\& Nurminen method stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.', 'statisticalMethod': 'Miettinen & Nurminen Method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 21 months', 'description': 'ORR was defined as the percentage of participants who achieved a confirmed complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesion) per RECIST 1.1 as assessed by BICR.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 21 months', 'description': 'For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who experienced a confirmed CR or PR were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 31 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.11', 'groupId': 'OG000', 'lowerLimit': '-9.95', 'upperLimit': '-4.26'}, {'value': '-4.03', 'groupId': 'OG001', 'lowerLimit': '-7.05', 'upperLimit': '-1.00'}]}]}], 'analyses': [{'pValue': '0.1318', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Square (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.08', 'ciLowerLimit': '-7.09', 'ciUpperLimit': '0.93', 'pValueComment': 'Two-sided p-value based on t-test.', 'estimateComment': 'Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \\& stratified by geographic region, presence of liver metastasis \\& time from diagnosis of metastatic disease to randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.13', 'groupId': 'OG000', 'lowerLimit': '-9.86', 'upperLimit': '-4.40'}, {'value': '-6.17', 'groupId': 'OG001', 'lowerLimit': '-9.08', 'upperLimit': '-3.27'}]}]}], 'analyses': [{'pValue': '0.6370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-4.93', 'ciUpperLimit': '3.02', 'pValueComment': 'Two-sided p-value based on t-test.', 'estimateComment': 'Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \\& stratified by geographic region, presence of liver metastasis \\& time from diagnosis of metastatic disease to randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '8.04', 'groupId': 'OG000', 'lowerLimit': '3.93', 'upperLimit': '12.15'}, {'value': '4.18', 'groupId': 'OG001', 'lowerLimit': '-0.16', 'upperLimit': '8.53'}]}]}], 'analyses': [{'pValue': '0.1846', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.86', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '9.57', 'pValueComment': 'Two-sided p-value based on t-test.', 'estimateComment': 'Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \\& stratified by geographic region, presence of liver metastasis \\& time from diagnosis of metastatic disease to randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-C30 assessment data available for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': '4.33', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '8.30'}, {'value': '3.77', 'groupId': 'OG001', 'lowerLimit': '-0.44', 'upperLimit': '7.98'}]}]}], 'analyses': [{'pValue': '0.8410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-4.96', 'ciUpperLimit': '6.08', 'pValueComment': 'Two-sided p-value based on t-test.', 'estimateComment': 'Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \\& stratified by geographic region, presence of liver metastasis \\& time from diagnosis of metastatic disease to randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had at least one EORTC QLQ-CR29 assessment data available for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, lower and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.58', 'pValueComment': 'One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) \\& QoL combined score (EORTC QLQ-C30 Item 30). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': 'NA'}, {'value': '20.3', 'comment': 'NA = Upper limit was not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9704', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.33', 'pValueComment': 'One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, lower and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, lower and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '1.11', 'ciUpperLimit': '2.98', 'pValueComment': 'One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-C30 assessment data available at baseline for this outcome measure were analyzed.'}, {'type': 'SECONDARY', 'title': 'TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'OG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, lower and upper limit were not reached due to insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '1.06', 'ciUpperLimit': '3.26', 'pValueComment': 'One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\\>=18 months, \\<18 months).', 'estimateComment': "HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \\& time from initial diagnosis of metastatic disease to randomization", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have received at least one dose of the study intervention and had EORTC QLQ-CR29 assessment data available at baseline for this outcome measure were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'FG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '220'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Favezelimab/Pembrolizumab', 'description': 'Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.'}, {'id': 'BG001', 'title': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants received 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle OR 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'categories': [{'title': 'Asia Pacific', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'EMEA/Americas', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants was stratified by the geographic region of the participants (Asia Pacific or Europe, the Middle East and Africa \\[EMEA\\]/Americas).', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of Liver Metastasis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants was stratified by the presence of liver metastasis (Yes or No).', 'unitOfMeasure': 'Participants'}, {'title': 'Time from Initial Diagnosis of Metastatic Disease to Randomization', 'classes': [{'categories': [{'title': '≥18 months', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': '<18 months', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomization of participants was stratified by the time from initial diagnosis of metastatic disease to randomization (≥18 months or \\<18 months).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-22', 'size': 3181112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-31T13:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open-label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2021-09-29', 'resultsFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-28', 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 33 months', 'description': 'OS was defined as the time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to approximately 21 months', 'description': 'PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.'}, {'measure': 'Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 21 months', 'description': 'ORR was defined as the percentage of participants who achieved a confirmed complete response (CR: Disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesion) per RECIST 1.1 as assessed by BICR.'}, {'measure': 'Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR', 'timeFrame': 'Up to approximately 21 months', 'description': 'For participants who demonstrate confirmed CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions), duration of response was defined as the time from the first documented evidence of CR or PR until progressive disease (PD) or death due to any cause. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation.'}, {'measure': 'Number of Participants Who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to approximately 31 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented.'}, {'measure': 'Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.'}, {'measure': 'Change From Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score', 'timeFrame': 'Baseline and up to approximately 8 weeks', 'description': 'The EORTC QLQ-CR29 is a health-related quality-of life (QoL) questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.'}, {'measure': 'Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in GHS (EORTC QLQ-C30 Item 29) \\& QoL combined score (EORTC QLQ-C30 Item 30). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.'}, {'measure': 'TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.'}, {'measure': 'TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.'}, {'measure': 'TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score', 'timeFrame': 'Baseline and up to approximately 38 months', 'description': 'TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1),', 'Programmed Cell Death Receptor Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26350&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil).\n\nThe primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator.\n* Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.\n* Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.\n* Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.\n* Has a life expectancy of at least 3 months, based on the investigator assessment.\n* Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.\n* Has adequate organ function.\n\nExclusion Criteria:\n\n* Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.\n* Has a history of acute or chronic pancreatitis.\n* Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Has urine protein greater than or equal to 1g/24h.\n* A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.\n* Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation \\[CD\\] 137).\n* Has previously received regorafenib or TAS-102.\n* Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has had an allogenic tissue/solid organ transplant."}, 'identificationModule': {'nctId': 'NCT05064059', 'briefTitle': 'A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)', 'orgStudyIdInfo': {'id': '4280A-007'}, 'secondaryIdInfos': [{'id': 'MK-4280A-007', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2031210482', 'type': 'REGISTRY', 'domain': 'jRCT(Japan Registry of Clinical Trials)'}, {'id': '2024-511043-25-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1302-9933', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2021-001309-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Favezelimab/Pembrolizumab', 'description': 'Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.', 'interventionNames': ['Biological: favezelimab/pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (Regorafenib or TAS-102)', 'description': "At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.", 'interventionNames': ['Drug: regorafenib', 'Drug: TAS-102']}], 'interventions': [{'name': 'favezelimab/pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-4280A'], 'description': 'Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion', 'armGroupLabels': ['Favezelimab/Pembrolizumab']}, {'name': 'regorafenib', 'type': 'DRUG', 'otherNames': ['STIVARGA®', 'REGONIX®'], 'description': 'Oral', 'armGroupLabels': ['Standard of Care (Regorafenib or TAS-102)']}, {'name': 'TAS-102', 'type': 'DRUG', 'otherNames': ['LONSURF®'], 'description': 'Oral', 'armGroupLabels': ['Standard of Care (Regorafenib or TAS-102)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital ( Site 1148)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sibley Memorial Hospital ( Site 1143)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute ( Site 1139)', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey ( Site 1105)', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center ( Site 1703)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon 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