Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04907851
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2021-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.tilston@redxpharma.com', 'phone': '+44 (0)7787 983 638', 'title': 'Craig Tilston', 'organization': 'Redx Pharma Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)].', 'description': 'Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.\n\nAll the AEs from Screening till study termination have been presented here before, and after receiving treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 15, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 10, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Immune-mediated thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Steatorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasal herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arachnoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary hesitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nail discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Onychomadesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Immune-mediated myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Immune-mediated adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Biliary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stoma site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The estimate of PFS at 6-months could not be calculated as the final surviving patient withdrew consent and was censored at 2.73 months. The Kaplan-Meier survival curve, from which the estimates would have been derived, did not extend to 6-months.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '20.53'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 months', 'description': 'The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'PRIMARY', 'title': 'Combination Therapy (Module 3): Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '14.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 23 months', 'description': 'The anti-tumour activity of RXC004 as a combination therapy was assessed. ORR was defined as the percentage of patients with a best overall response of complete response or partial response based on local investigator assessment as defined in RECIST 1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Monotherapy (Modules 1 and 2): ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '58.18'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '21.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 was assessed. ORR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '58.18'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '10.41', 'upperLimit': '45.56'}, {'value': '31.6', 'groupId': 'OG002', 'lowerLimit': '14.75', 'upperLimit': '53.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. DCR was defined as the percentage of patients with a best overall response of either CR, PR or stable disease (SD) for at least 6 weeks.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): PFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004(1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6w within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'comment': 'Due to insufficient number of participants with events, estimates were not calculable using methodology specified in SAP.', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': 'NA'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '2.04'}, {'value': '1.41', 'groupId': 'OG002', 'lowerLimit': '1.41', 'upperLimit': '2.53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Best Percentage Change in Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004(1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion q6wwithin 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.67', 'groupId': 'OG000', 'lowerLimit': '-57.1', 'upperLimit': '93.2'}, {'value': '20.06', 'groupId': 'OG001', 'lowerLimit': '-78.8', 'upperLimit': '87.9'}, {'value': '30.61', 'groupId': 'OG002', 'lowerLimit': '-33.3', 'upperLimit': '61.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. The best percentage change in tumour size was determined at a patient level. For each patient, it represents the largest decrease (or smallest increase) in tumour size. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of all target lesions.', 'unitOfMeasure': 'Percentage change in tumour size', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'comment': 'Due to insufficient number of participants with events, estimates were not calculable using methodology specified in SAP.', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '13.6'}, {'value': '4.7', 'comment': 'Due to insufficient number of participants with events, therefore data was not calculated as per methodology specified in SAP.', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. OS was defined as the time from first day of study treatment until death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'title': 'Cycle 0 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '107', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '43.9', 'groupId': 'OG001'}, {'value': '57.6', 'spread': '44.1', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '140', 'spread': '50.8', 'groupId': 'OG000'}, {'value': '99.5', 'spread': '50.7', 'groupId': 'OG001'}, {'value': '67.5', 'spread': '56.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)', 'description': 'The pharmacokinetics (PK) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'title': 'Cycle 0 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '51.3', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '45.9', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.49', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '51.3', 'groupId': 'OG001'}, {'value': '1.66', 'spread': '45.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)', 'description': 'The PK (tmax) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Concentration Across the Dosing Interval (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '110', 'groupId': 'OG001'}, {'value': '9.79', 'spread': '153', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 1 Day 15 (The cycle was 21 days in length) (Up to 23 months)', 'description': 'The PK (Cmin) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Terminal Rate Constant (λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0660', 'spread': '36.5', 'groupId': 'OG000'}, {'value': '0.0660', 'spread': '32.4', 'groupId': 'OG001'}, {'value': '0.0655', 'spread': '28.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (λz) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'one per hour (1/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '36.5', 'groupId': 'OG000'}, {'value': '9.90', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '29.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1(The cycle was 21 days in length)', 'description': 'The PK (t½) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '891', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '690', 'spread': '43.5', 'groupId': 'OG001'}, {'value': '511', 'spread': '47.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (AUC0-∞) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Total Plasma Clearance After Oral Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2250', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '2900', 'spread': '43.5', 'groupId': 'OG001'}, {'value': '2940', 'spread': '47.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK(CL/F) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'milliliter per hour (mL/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution After Oral Administration (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '29700', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '41400', 'spread': '31.0', 'groupId': 'OG001'}, {'value': '44800', 'spread': '40.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (Vz/F) of RXC004 as a monotherapy and as a combination therapy was assessed.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all patients in the safety analysis set who have had at least one blood sample.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'OG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'OG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line Soc treatment.'}], 'classes': [{'title': 'Treatment-Emergent Adverse Event (TEAE)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Related TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Grade >=3 TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Related grade>=3 TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to permanent discontinuation or reduction or interruption of RXC004', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to permanent discontinuation of RXC004', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to reduction of RXC004', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to interruption of RXC004', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to permanent discontinuation or 0 6 interruption of Pembrolizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to permanent discontinuation of 0 5 Pembrolizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to interruption of Pembrolizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)', 'description': 'The safety, and tolerability profile of RXC004 as a monotherapy and as a combination therapy was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all patients who enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg once daily \\[QD\\] orally) within 6 weeks of progression following 1st line Standard of Care (SoC) treatment.'}, {'id': 'FG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'FG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'This study was conducted from 10 December 2021 to 22 Nov 2023 at multiple centers in Australia, and United Kingdom.', 'preAssignmentDetails': 'Patients who met the inclusion criteria, and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the Schedule of Assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Module 1-RNF43 Mutated Advanced (Unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) were recruited and dosed with RXC004 (2 mg QD orally) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'BG001', 'title': 'Module 2-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'BG002', 'title': 'Module 3-Advanced (Unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) were recruited and dosed with RXC004 (1.5 mg QD orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression following 1st line SoC treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '7.94', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '14.72', 'groupId': 'BG001'}, {'value': '58.1', 'spread': '10.85', 'groupId': 'BG002'}, {'value': '58.1', 'spread': '12.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Not Stated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all patients who were enrolled and received at least one dose of RXC004 in Modules 1 and 2, and at least one dose of RXC004 or pembrolizumab in Module 3.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-04', 'size': 10965323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-07T11:29', 'hasProtocol': True}, {'date': '2024-02-15', 'size': 3326219, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-07T11:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2021-05-25', 'resultsFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2021-05-28', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-25', 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monotherapy (Modules 1 and 2): Progression Free Survival Rate at 6 Months', 'timeFrame': 'At 6 months', 'description': 'The anti-tumour activity of RXC004 was assessed. Progression free survival rate at 6 months was defined as the percentage of patients who remained alive and free of progression at 6 months according to Kaplan-Meier estimates.'}, {'measure': 'Combination Therapy (Module 3): Objective Response Rate (ORR)', 'timeFrame': 'Up to 23 months', 'description': 'The anti-tumour activity of RXC004 as a combination therapy was assessed. ORR was defined as the percentage of patients with a best overall response of complete response or partial response based on local investigator assessment as defined in RECIST 1.1.'}], 'secondaryOutcomes': [{'measure': 'Monotherapy (Modules 1 and 2): ORR', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 was assessed. ORR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment as defined in RECIST 1.1.'}, {'measure': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Disease Control Rate (DCR)', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. DCR was defined as the percentage of patients with a best overall response of either CR, PR or stable disease (SD) for at least 6 weeks.'}, {'measure': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): PFS', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. PFS was defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression) regardless whether the patient withdrew from the assigned study treatment or received another anticancer prior to progression.'}, {'measure': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Best Percentage Change in Tumor Size', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. The best percentage change in tumour size was determined at a patient level. For each patient, it represents the largest decrease (or smallest increase) in tumour size. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of all target lesions.'}, {'measure': 'Monotherapy (Modules 1 and 2) and Combination Therapy (Module 3): Overall Survival (OS)', 'timeFrame': 'Up to 23 months', 'description': 'The preliminary efficacy of RXC004 as a monotherapy and as a combination therapy was assessed. OS was defined as the time from first day of study treatment until death due to any cause.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)', 'description': 'The pharmacokinetics (PK) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'At Cycle 0 Day 1 and Cycle 1 Day 15 (Each cycle was 21 days in length)', 'description': 'The PK (tmax) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Minimum Observed Concentration Across the Dosing Interval (Cmin)', 'timeFrame': 'At Cycle 1 Day 15 (The cycle was 21 days in length) (Up to 23 months)', 'description': 'The PK (Cmin) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Terminal Rate Constant (λz)', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (λz) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Terminal Half-life (t½)', 'timeFrame': 'At Cycle 0 Day 1(The cycle was 21 days in length)', 'description': 'The PK (t½) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (AUC0-∞) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Total Plasma Clearance After Oral Administration (CL/F)', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK(CL/F) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Apparent Volume of Distribution After Oral Administration (Vz/F)', 'timeFrame': 'At Cycle 0 Day 1 (The cycle was 21 days in length)', 'description': 'The PK (Vz/F) of RXC004 as a monotherapy and as a combination therapy was assessed.'}, {'measure': 'Number of Patients With Adverse Events (AEs)', 'timeFrame': 'From time of signature of main study informed consent form throughout the treatment period and until the 30 days after last dose of RXC004 (Up to 23 months)', 'description': 'The safety, and tolerability profile of RXC004 as a monotherapy and as a combination therapy was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open-Label', 'RXC004', 'Ring finger protein 43', 'Pancreatic ductal adenocarcinoma', 'Biliary tract cancer', 'Efficacy', 'Safety', 'Pharmacokinetics', 'Pancreatic cancer', 'Cholangiocarcinoma', 'Gallbladder', 'Ampullary Cancer', 'Ampulla of Vater', 'MK-3475-E86', 'zamaporvint'], 'conditions': ['Advanced Solid Tumours']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.', 'detailedDescription': 'This Phase II, modular, open label, multicentre study initially opened with ring finger protein 43 (RNF43) loss of function (LoF) mutation-positive pancreatic ductal adenocarcinoma (PDAC) (Module 1) and molecularly unselected biliary tract cancer (BTC) (Module 2) modules. Module 3 will investigate RXC004 in combination with pembrolizumab in BTC. Modules 1 and 2 are monotherapies and Module 3 is the combination therapy.\n\nThe primary objective of the study is to assess the preliminary efficacy of RXC004 in each module. This will be evaluated in terms of progression free survival (PFS) at 6 months in Modules 1 and 2, and in terms of Objective response rate (ORR) in Module 3. Following radiological progression, patients will be followed-up for survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Core Inclusion Criteria:\n\n* At least one lesion that is measurable by RECIST 1.1 at baseline (within 6 weeks prior to start of study treatment).\n* Mandatory paired biopsies; Patients must have at least one lesion suitable for biopsy at screening\n* Adequate organ and marrow function\n* Female patients of childbearing potential must have a negative pregnancy test prior to start of dosing\n* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use a highly effective method of contraception during the study from the time of treatment initiation, and for at least 5 months after the last dose of study drug.\n\nModule 1 (PDAC) Specific Inclusion Criteria\n\n* Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) PDAC, with documented loss of function tumour mutation in RNF43\n* Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic PDAC (Stage III/IV), with clear evidence of radiological disease progression\n* Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression\n* Karnofsky performance status ≥70.\n\nModule 2 and Module 3 (BTC) Specific Inclusion Criteria\n\n* Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) BTC (intrahepatic or extrahepatic cholangiocarcinoma, ampulla of Vater, or gallbladder cancer)\n* Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic BTC, with clear evidence of radiological disease progression\n* Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression\n* ECOG status 0 or 1.\n\nCore Exclusion Criteria:\n\n* Prior therapy with a compound of the same mechanism of action as RXC004\n* Patients at higher risk of bone fractures\n* Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment\n* Patients who have any history of an active (requiring treatment) other malignancy within 2 years of study entry\n* Patients with known or suspected brain metastases\n* Use of anti-neoplastic agents\n* Patients with a known hypersensitivity to any RXC004 excipients\n* Patients with a contra-indication for denosumab treatment\n* Patients who are pregnant or breast-feeding\n* Known active human immunodeficiency viruses (HIV), hepatitis B (HBV), or hepatitis C (HCV) infections\n* Use of any live or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment\n* Mean resting corrected QTcF \\>470 ms, obtained from triplicate ECGs performed at screening.\n\nThere are no exclusion criteria specific to Modules 1 and 2.\n\nModule 3 Specific Exclusion Criteria:\n\n* Patients with any contraindication to the use of pembrolizumab as per approved label\n* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher AE\n* Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of pembrolizumab in this study\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 (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease\n* Has an active infection requiring systemic therapy\n* Patients with a history of allogeneic tissue/solid organ transplant\n* Patients with active infections, including tuberculosis, HIV, HBV, or HCV'}, 'identificationModule': {'nctId': 'NCT04907851', 'acronym': 'KEYNOTE-E86', 'briefTitle': 'A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Redx Pharma Ltd'}, 'officialTitle': 'A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care', 'orgStudyIdInfo': {'id': 'RXC004/0003'}, 'secondaryIdInfos': [{'id': 'MK-3475-E86', 'type': 'OTHER', 'domain': 'Collaboration requirements'}, {'id': 'KEYNOTE-E86', 'type': 'OTHER', 'domain': 'Collaboration requirements'}, {'id': '2020-005804-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'description': 'Patients (Karnofsky performance status ≥70) will be recruited and dosed with RXC004 (2 mg once daily \\[QD\\], orally) within 6 weeks of progression following 1st line SoC treatment.', 'interventionNames': ['Drug: RXC004', 'Biological: Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'description': 'Patients (Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0-1) will be recruited and dosed with RXC004 within 6 weeks of progression, following 1st line SoC treatment.', 'interventionNames': ['Drug: RXC004', 'Biological: Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy', 'description': 'Patients (ECOG performance status 0-1) will be recruited and dosed with RXC004 (1.5 mg QD, orally) in combination with pembrolizumab 400 mg IV infusion every 6 weeks (q6w) within 6 weeks of progression, following 1st line Soc treatment.', 'interventionNames': ['Drug: RXC004', 'Biological: Denosumab', 'Biological: pembrolizumab']}], 'interventions': [{'name': 'RXC004', 'type': 'DRUG', 'otherNames': ['zamaporvint'], 'description': 'RXC004 will be administered orally, 2 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.', 'armGroupLabels': ['Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)']}, {'name': 'RXC004', 'type': 'DRUG', 'otherNames': ['zamaporvint'], 'description': 'RXC004 will be administered orally, 2 mg QD (Cohort 1, Module 2) and 1 mg QD (Cohort 2, Module 2); Dose Formulation: 0.5 mg or 1 mg capsules.', 'armGroupLabels': ['Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)']}, {'name': 'RXC004', 'type': 'DRUG', 'otherNames': ['zamaporvint'], 'description': 'RXC004 will be administered orally, 1.5 mg QD; Dose Formulation: 0.5 mg or 1 mg capsules.', 'armGroupLabels': ['Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy']}, {'name': 'Denosumab', 'type': 'BIOLOGICAL', 'description': 'Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month; Use: Prophylactic', 'armGroupLabels': ['Module 1 - RNF43 Mutated Advanced (unresectable)/Metastatic Pancreatic Cancer (Stage III/IV)', 'Module 2 -Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage III/IV)', 'Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy']}, {'name': 'pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®'], 'description': 'Pembrolizumab will be administered via intravenous infusion, 400 mg dose once every 6 weeks', 'armGroupLabels': ['Module 3-Advanced (unresectable)/Metastatic Biliary Tract Cancer (Stage Ill/IV) Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '3304', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital - Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'CB2 0XY', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Care', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Cancer Institute - Haemato-Oncology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London Foundation NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust - Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust - Medical Oncology', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Cancer and Haematology Centre Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SM25PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital (Surrey)', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Redx Pharma Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}